Trial Outcomes & Findings for Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma (NCT NCT00352027)

Results Overview

The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

3 years

Results posted on

2023-09-22

Participant Flow

Participants were enrolled between July 2006 and March 2012.

One participant was determined to be ineligible after enrollment and prior to start of therapy.

Participant milestones

Participant milestones
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
Overall Study STARTED	80
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
Overall Study Progressive disease	3

Baseline Characteristics

Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
Age, Continuous	15.10 years STANDARD_DEVIATION 3.15 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Participating Site Location Dana Farber Cancer Institute, Boston, MA	21 participants n=5 Participants
Participating Site Location Main Medical Center, Portland, ME	2 participants n=5 Participants
Participating Site Location Massachusetts General Hospital, Boston, MA	1 participants n=5 Participants
Participating Site Location Rady Children's Hospital, San Diego, CA	1 participants n=5 Participants
Participating Site Location St. Jude Children's Research Hospital, Memphis, TN	33 participants n=5 Participants
Participating Site Location Stanford University Medical Center, Palo Alto, CA	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
3-year Event-Free Survival Probability	0.887 probability Interval 0.821 to 0.959	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 years

Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Disease Failure Rate Within Radiation Fields	0.1125 proportion of participants Interval 0.05591 to 0.2076	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: from first enrollment date up to 3 years follow-up

The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Local and Distant Failure for Children Treated With Tailored-field Radiation Cumulative incidence of distant failure at 3 years	0.0375 probability that the event occurs Interval 0.0099 to 0.0967	—	—	—	—	—	—	—
Local and Distant Failure for Children Treated With Tailored-field Radiation Cumulative incidence of local failure at 3 years	0.1127 probability that the event occurs Interval 0.055 to 0.1932	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Prognostic Factors for Treatment Failure: Age	11 events	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=58 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=54 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=51 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.4.0: Total Score	80.9 units on a scale Standard Deviation 12.7	74.4 units on a scale Standard Deviation 16.5	75.3 units on a scale Standard Deviation 17.8	83.1 units on a scale Standard Deviation 14.6	84.5 units on a scale Standard Deviation 16.6	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=61 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=60 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=54 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning	83.2 units on a scale Standard Deviation 17.1	68.4 units on a scale Standard Deviation 23.1	69.1 units on a scale Standard Deviation 24.6	80.8 units on a scale Standard Deviation 17.1	85.2 units on a scale Standard Deviation 15.6	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=59 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=54 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=51 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	79.3 units on a scale Standard Deviation 13	77.6 units on a scale Standard Deviation 15.4	78.6 units on a scale Standard Deviation 16.8	84.3 units on a scale Standard Deviation 15.1	84.3 units on a scale Standard Deviation 17.9	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=61 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=60 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=54 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	72.6 units on a scale Standard Deviation 18.0	75.3 units on a scale Standard Deviation 19.3	75.7 units on a scale Standard Deviation 20.8	84.5 units on a scale Standard Deviation 17.8	81.6 units on a scale Standard Deviation 24.1	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=62 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=60 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=54 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning	90.9 units on a scale Standard Deviation 11.1	88.6 units on a scale Standard Deviation 13.0	88.0 units on a scale Standard Deviation 15.6	90.1 units on a scale Standard Deviation 12.5	91.1 units on a scale Standard Deviation 13.6	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=60 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=54 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=51 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning	73.1 units on a scale Standard Deviation 18.8	69.5 units on a scale Standard Deviation 21.8	72.6 units on a scale Standard Deviation 22.2	78.4 units on a scale Standard Deviation 20.6	81.3 units on a scale Standard Deviation 21.6	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=60 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=37 Participants Evaluation completed following radiation therapy.	Off-therapy n=53 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Total Score	—	74.1 units on a scale Standard Deviation 15.3	74.2 units on a scale Standard Deviation 16.8	81.7 units on a scale Standard Deviation 14.6	83.5 units on a scale Standard Deviation 17.2	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=61 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=41 Participants Evaluation completed following radiation therapy.	Off-therapy n=55 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	—	63.9 units on a scale Standard Deviation 25.4	71.5 units on a scale Standard Deviation 24.6	79.9 units on a scale Standard Deviation 25.1	88.0 units on a scale Standard Deviation 17.8	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=61 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=41 Participants Evaluation completed following radiation therapy.	Off-therapy n=55 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Nausea	—	62.7 units on a scale Standard Deviation 24.0	60.1 units on a scale Standard Deviation 23.5	76.7 units on a scale Standard Deviation 20.9	81.6 units on a scale Standard Deviation 23.1	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=60 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=54 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	—	71.8 units on a scale Standard Deviation 29.0	70.9 units on a scale Standard Deviation 32.6	68.1 units on a scale Standard Deviation 37.3	80.1 units on a scale Standard Deviation 25.9	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=61 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=41 Participants Evaluation completed following radiation therapy.	Off-therapy n=54 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	—	89.2 units on a scale Standard Deviation 15.5	82 units on a scale Standard Deviation 22.5	89.4 units on a scale Standard Deviation 16.6	87.3 units on a scale Standard Deviation 19.1	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=61 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=41 Participants Evaluation completed following radiation therapy.	Off-therapy n=54 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Worry	—	71.2 units on a scale Standard Deviation 22.5	72.2 units on a scale Standard Deviation 24.7	74.5 units on a scale Standard Deviation 27.2	76.0 units on a scale Standard Deviation 25.0	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=61 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=41 Participants Evaluation completed following radiation therapy.	Off-therapy n=55 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	—	79.1 units on a scale Standard Deviation 19.4	78.2 units on a scale Standard Deviation 21.4	87.0 units on a scale Standard Deviation 17.3	82.0 units on a scale Standard Deviation 23.2	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=61 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=54 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	—	77.6 units on a scale Standard Deviation 22.1	81.3 units on a scale Standard Deviation 22.6	81.4 units on a scale Standard Deviation 22.4	84.7 units on a scale Standard Deviation 22.9	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=61 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=39 Participants Evaluation completed following radiation therapy.	Off-therapy n=54 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), PedsQL v.3.0: Communication	—	80.7 units on a scale Standard Deviation 19.9	83.0 units on a scale Standard Deviation 22.5	87.2 units on a scale Standard Deviation 22.8	89.0 units on a scale Standard Deviation 19.3	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

The patient's degree of discomfort from specific treatment-related symptoms across multiple time points. Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=57 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=59 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=52 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=50 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Patient Quality of Life (QoL), Symptom Distress Scale	17.3 units on a scale Standard Deviation 6.5	19.6 units on a scale Standard Deviation 6.6	18.1 units on a scale Standard Deviation 6.1	15.1 units on a scale Standard Deviation 4.8	14.3 units on a scale Standard Deviation 5.3	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=61 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=52 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=50 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=36 Participants Evaluation completed following radiation therapy.	Off-therapy n=47 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score	77.6 units on a scale Standard Deviation 16.7	69.1 units on a scale Standard Deviation 17.9	72.3 units on a scale Standard Deviation 18.5	77.8 units on a scale Standard Deviation 16.3	83.5 units on a scale Standard Deviation 16.4	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=64 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=56 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning	79.8 units on a scale Standard Deviation 20.7	65.3 units on a scale Standard Deviation 23.2	67.3 units on a scale Standard Deviation 25.2	73.6 units on a scale Standard Deviation 21.3	84.6 units on a scale Standard Deviation 18.6	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=61 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=52 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=50 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=36 Participants Evaluation completed following radiation therapy.	Off-therapy n=47 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	76.2 units on a scale Standard Deviation 16.8	71.0 units on a scale Standard Deviation 16.7	74.1 units on a scale Standard Deviation 17.9	79.0 units on a scale Standard Deviation 16.1	88.0 units on a scale Standard Deviation 17.0	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=64 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=56 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	67.7 units on a scale Standard Deviation 20.4	65.4 units on a scale Standard Deviation 18.4	68.1 units on a scale Standard Deviation 23.7	73.0 units on a scale Standard Deviation 20.1	82.0 units on a scale Standard Deviation 18.9	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=64 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=56 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning	86.1 units on a scale Standard Deviation 18.6	83.0 units on a scale Standard Deviation 16.0	80.7 units on a scale Standard Deviation 18.5	85.1 units on a scale Standard Deviation 16.3	89.1 units on a scale Standard Deviation 16.8	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=61 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=52 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=50 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=36 Participants Evaluation completed following radiation therapy.	Off-therapy n=47 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning	74.4 units on a scale Standard Deviation 20.6	62.8 units on a scale Standard Deviation 25.0	70.8 units on a scale Standard Deviation 22.7	75.6 units on a scale Standard Deviation 20.8	78.9 units on a scale Standard Deviation 21.2	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=37 Participants Evaluation completed following radiation therapy.	Off-therapy n=48 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score	—	71.7 units on a scale Standard Deviation 16.7	69.3 units on a scale Standard Deviation 19.0	74.5 units on a scale Standard Deviation 17.7	80.0 units on a scale Standard Deviation 16.4	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=56 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	—	61.2 units on a scale Standard Deviation 24.3	61.8 units on a scale Standard Deviation 30.5	73.1 units on a scale Standard Deviation 25.9	82.7 units on a scale Standard Deviation 23.4	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=57 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=39 Participants Evaluation completed following radiation therapy.	Off-therapy n=48 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea	—	61.2 units on a scale Standard Deviation 24.4	57.4 units on a scale Standard Deviation 29.2	72.2 units on a scale Standard Deviation 26.6	83.2 units on a scale Standard Deviation 22.6	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	—	70.0 units on a scale Standard Deviation 32.1	60.0 units on a scale Standard Deviation 35.0	63.1 units on a scale Standard Deviation 36.6	73.8 units on a scale Standard Deviation 31.7	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=57 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=56 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	—	81.9 units on a scale Standard Deviation 21.8	72.6 units on a scale Standard Deviation 28.4	78.5 units on a scale Standard Deviation 26.8	81.8 units on a scale Standard Deviation 20.8	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=56 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry	—	70 units on a scale Standard Deviation 24.5	69.2 units on a scale Standard Deviation 25.3	71.9 units on a scale Standard Deviation 24.1	78.7 units on a scale Standard Deviation 19.4	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=57 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=40 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	—	77.6 units on a scale Standard Deviation 21.8	79.5 units on a scale Standard Deviation 20.4	78.6 units on a scale Standard Deviation 21.8	79.9 units on a scale Standard Deviation 23.4	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=56 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=50 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	—	74.9 units on a scale Standard Deviation 22.9	72.2 units on a scale Standard Deviation 21.9	73.7 units on a scale Standard Deviation 24.2	76.3 units on a scale Standard Deviation 24.4	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=56 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=50 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication	—	79.2 units on a scale Standard Deviation 25.9	80.4 units on a scale Standard Deviation 24.9	80.3 units on a scale Standard Deviation 22.6	84.3 units on a scale Standard Deviation 20.3	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=57 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=50 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=49 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=34 Participants Evaluation completed following radiation therapy.	Off-therapy n=47 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score	-2.9 units on a scale Standard Deviation 13.3	-4.8 units on a scale Standard Deviation 13.8	-4.8 units on a scale Standard Deviation 14.7	-5 units on a scale Standard Deviation 10.7	-2.9 units on a scale Standard Deviation 14.8	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=60 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=37 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning	-2.9 units on a scale Standard Deviation 16.4	-2.3 units on a scale Standard Deviation 16.9	-1.9 units on a scale Standard Deviation 23.3	-5.4 units on a scale Standard Deviation 15.8	-2 units on a scale Standard Deviation 19.1	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=58 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=50 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=49 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=34 Participants Evaluation completed following radiation therapy.	Off-therapy n=47 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health	-2.8 units on a scale Standard Deviation 14.4	-6.4 units on a scale Standard Deviation 14.4	-6.3 units on a scale Standard Deviation 13.2	-5.6 units on a scale Standard Deviation 11.2	-3.3 units on a scale Standard Deviation 14.2	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=60 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=37 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning	-4.9 units on a scale Standard Deviation 18.8	-9.4 units on a scale Standard Deviation 17.9	-8.0 units on a scale Standard Deviation 14.2	-10.8 units on a scale Standard Deviation 14.3	-1.7 units on a scale Standard Deviation 18.8	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=61 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=37 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning	-5.3 units on a scale Standard Deviation 16.5	-5.7 units on a scale Standard Deviation 15.3	-7.4 units on a scale Standard Deviation 17.7	-5.0 units on a scale Standard Deviation 12.6	-3.3 units on a scale Standard Deviation 16.4	—	—	—

SECONDARY outcome

Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=59 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=50 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=49 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=34 Participants Evaluation completed following radiation therapy.	Off-therapy n=47 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning	1.3 units on a scale Standard Deviation 17.0	-5.3 units on a scale Standard Deviation 19.5	-4.1 units on a scale Standard Deviation 21.0	-3.4 units on a scale Standard Deviation 16.7	-4.3 units on a scale Standard Deviation 16.4	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=53 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=54 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=33 Participants Evaluation completed following radiation therapy.	Off-therapy n=46 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score	—	-1.5 units on a scale Standard Deviation 13	-5.2 units on a scale Standard Deviation 13.8	-4.5 units on a scale Standard Deviation 12.5	-5 units on a scale Standard Deviation 16.8	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt	—	-2.0 units on a scale Standard Deviation 16.5	-9.5 units on a scale Standard Deviation 23.6	-5.6 units on a scale Standard Deviation 23.4	-5.4 units on a scale Standard Deviation 19.8	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=37 Participants Evaluation completed following radiation therapy.	Off-therapy n=48 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea	—	-1.2 units on a scale Standard Deviation 15.8	-3.4 units on a scale Standard Deviation 21.9	-3.0 units on a scale Standard Deviation 22.4	-1.1 units on a scale Standard Deviation 22.2	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=55 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=54 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=48 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety	—	-0.2 units on a scale Standard Deviation 28.1	-9.3 units on a scale Standard Deviation 29.9	-2.2 units on a scale Standard Deviation 32.7	-8.7 units on a scale Standard Deviation 27.7	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=55 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=48 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety	—	-6.1 units on a scale Standard Deviation 21.9	-8.8 units on a scale Standard Deviation 26.4	-7.9 units on a scale Standard Deviation 23.7	-6.6 units on a scale Standard Deviation 26.7	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=48 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry	—	-0.7 units on a scale Standard Deviation 21.7	-3.9 units on a scale Standard Deviation 26.5	-2.7 units on a scale Standard Deviation 20.4	-0.5 units on a scale Standard Deviation 19.9	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=55 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=54 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=38 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems	—	-1.0 units on a scale Standard Deviation 20.7	0.14 units on a scale Standard Deviation 19	-8.0 units on a scale Standard Deviation 19	-4.0 units on a scale Standard Deviation 20	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=34 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance	—	-2.5 units on a scale Standard Deviation 21.0	-9.5 units on a scale Standard Deviation 22.5	-5.9 units on a scale Standard Deviation 25.7	-9.3 units on a scale Standard Deviation 20.5	—	—	—

SECONDARY outcome

Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=56 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=55 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=35 Participants Evaluation completed following radiation therapy.	Off-therapy n=49 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication	—	-0.3 units on a scale Standard Deviation 26.4	-3.6 units on a scale Standard Deviation 25.2	-7.4 units on a scale Standard Deviation 25.5	-6.3 units on a scale Standard Deviation 21.1	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=72 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score	-1.46 beta coefficient Interval -1.64 to -1.27	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=72 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning	-1.9 beta coefficient Interval -2.27 to -1.54	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=72 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health	-0.92 beta coefficient Interval -1.26 to -0.58	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=72 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning	-1.56 beta coefficient Interval -1.95 to -1.16	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=72 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning	-0.79 beta coefficient Interval -0.98 to -0.59	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=72 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning	-1.21 beta coefficient Interval -1.7 to -0.72	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score	-1.41 beta coefficient Interval -1.71 to -1.11	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt	-2.52 beta coefficient Interval -3.02 to -2.02	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea	-2.31 beta coefficient Interval -2.85 to -1.77	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety	-0.87 beta coefficient Interval -1.49 to -0.26	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety	-0.96 beta coefficient Interval -1.43 to -0.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry	-1.06 beta coefficient Interval -1.48 to -0.65	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems	-1.46 beta coefficient Interval -1.87 to -1.04	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance	-1.20 beta coefficient Interval -1.68 to -0.72	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months after the completion of therapy

Population: Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=67 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication	-1.35 beta coefficient Interval -1.74 to -0.96	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 years

Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=46 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
3-year Event-free Survival (EFS) Probability	0.887 probability Interval 0.821 to 0.959	0.844 probability Interval 0.745 to 0.957	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3-years

Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=46 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
3-year Overall Survival (OS) Probability	1.00 probability Interval 1.0 to 1.0	0.978 probability Interval 0.936 to 1.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 years

Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=46 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
3-year Local Failure-free Survival Probability	0.887 probability Interval 0.821 to 0.959	0.932 probability Interval 0.86 to 1.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 years

Population: Toxicities reported below for the current study (HOD05) include all reported toxicities from a participant's on-study date through 2/17/2016. Toxicities reported below for the HOD99 study include all those reported from a participant's on-study date through their off-study date.

Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=80 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=80 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=80 Participants Evaluation completed following radiation therapy.	Off-therapy n=46 Participants Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 n=46 Participants Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 n=46 Participants Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 n=46 Participants Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Toxicities With Grade >1 Nausea	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Alanine transaminase (ALT)	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Allergic reaction/hypersensitivity	0 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Constipation	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Febrile neutropenia	0 adverse events	7 adverse events	1 adverse events	0 adverse events	0 adverse events	5 adverse events	2 adverse events	0 adverse events
Toxicities With Grade >1 Glucose	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Toxicities With Grade >1 Infection with Grade 3 or 4 neutrophils	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Infection - Other	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Lymphopenia	0 adverse events	22 adverse events	7 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Mucositis/stomatitis (functional/symptomatic)	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Neuropathy: sensory	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Platelets	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Sodium	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Syndromes - Other	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Thrombosis/embolism (vascular access-related)	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Thrombosis/thrombus/embolism	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Vomiting	0 adverse events	2 adverse events	0 adverse events	0 adverse events	1 adverse events	4 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Potassium	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Hemoglobin	0 adverse events	26 adverse events	6 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Hypoxia	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Aspartate transaminase (AST)	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Fever (in the absence of neutropenia)	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 GGT (gamma-Glutamyltranspeptidase)	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Ileus, GI (functional obstruction of bowel)	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Infection with normal ANC or Grade 1-2 neutrophils	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Infection with unknown ANC	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Insomnia	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Leukocytes (total WBC)	0 adverse events	41 adverse events	15 adverse events	0 adverse events	0 adverse events	19 adverse events	5 adverse events	0 adverse events
Toxicities With Grade >1 Neuropathy: motor	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Toxicities With Grade >1 Neutrophils/granulocytes (ANC/AGC)	0 adverse events	24 adverse events	32 adverse events	0 adverse events	0 adverse events	9 adverse events	30 adverse events	0 adverse events
Toxicities With Grade >1 Pain	0 adverse events	5 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events
Toxicities With Grade >1 Phosphate	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: 3 years follow-up

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Prognostic Factors for Treatment Failure: Gender Male	5 events	—	—	—	—	—	—	—
Prognostic Factors for Treatment Failure: Gender Female	6 events	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 3 years follow-up

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Prognostic Factors for Treatment Failure: Histology Classical, Nodular Sclerosing	10 events	—	—	—	—	—	—	—
Prognostic Factors for Treatment Failure: Histology Other	1 events	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage \<III showed a better outcome but was not statistically significant.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=80 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Prognostic Factors for Treatment Failure: Stage Stage <III	8 events	—	—	—	—	—	—	—
Prognostic Factors for Treatment Failure: Stage Stage ≥III	3 events	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1, 2, 5, and 10 years post therapy

Population: At each time point, a participant underwent an Echocardiogram (ECHO). Data was unavailable for patients who did not undergo the Echocardiogram at that time point.

Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=68 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=58 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=38 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=16 Participants Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram) Normal	68 Participants	57 Participants	36 Participants	15 Participants	—	—	—	—
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram) Abnormal	0 Participants	1 Participants	2 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 1, 2, 5, and 10 years post therapy

Population: At each time point, a participant underwent an Electrocardiogram (EKG). Data was unavailable for patients who did not undergo the Electrocardiogram at that time point.

Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=56 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=52 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=28 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=16 Participants Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram) Normal	51 Participants	44 Participants	24 Participants	10 Participants	—	—	—	—
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram) Abnormal	5 Participants	8 Participants	4 Participants	6 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 1, 2, 5, and 10 years post therapy

Population: At each time point, participants who received mediastinal/lung radiation or bleomycin underwent pulmonary function (PFT) assessment. Data was unavailable for patients who did not undergo the pulmonary function test at that time point.

Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=66 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=61 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=36 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=10 Participants Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function) Normal	46 Participants	41 Participants	25 Participants	9 Participants	—	—	—	—
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function) Abnormal	20 Participants	20 Participants	11 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 1, 2, 5, and 10 years post therapy

Population: At each time point, participants who received cervical and upper mediastinal radiation underwent TSH laboratory test. Data was unavailable for patients who did not undergo the TSH test at that time point.

For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings.

Outcome measures

Outcome measures
Measure	Stanford V Chemotherapy n=70 Participants Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.	Week 8 n=66 Participants Evaluation completed following 2 courses of therapy, approximately week 8 after start.	Week 12 n=46 Participants Evaluation completed following 4 courses of therapy, approximately week 16 after start.	After Radiation n=23 Participants Evaluation completed following radiation therapy.	Off-therapy Evaluation completed approximately 3-6 months following completion of therapy.	HOD99 - Grade 3 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH) Normal	60 Participants	54 Participants	37 Participants	20 Participants	—	—	—	—
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH) Hypothyroid	8 Participants	11 Participants	8 Participants	3 Participants	—	—	—	—
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH) Hyperthyroid	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH) Thyroid Nodule	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

Adverse Events

Stanford V Chemotherapy

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stanford V Chemotherapy n=80 participants at risk Intermediate risk single arm study defined as * EITHER Ann Arbor stage IB and IIIA, * OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph). Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
Vascular disorders Thrombosis/thrombus/embolism	1.2% 1/80 • Number of events 1 • Adverse events were collected from each participant's on-study date through 4 years after completion of therapy.

Other adverse events

Other adverse events
Measure	Stanford V Chemotherapy n=80 participants at risk Intermediate risk single arm study defined as * EITHER Ann Arbor stage IB and IIIA, * OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph). Participants receive 12 weeks of Stanford V chemotherapy: Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.
Blood and lymphatic system disorders Leukocytes (total WBC)	70.0% 56/80 • Number of events 111 • Adverse events were collected from each participant's on-study date through 4 years after completion of therapy.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	70.0% 56/80 • Number of events 118 • Adverse events were collected from each participant's on-study date through 4 years after completion of therapy.
Blood and lymphatic system disorders Hemoglobin	40.0% 32/80 • Number of events 48 • Adverse events were collected from each participant's on-study date through 4 years after completion of therapy.
Blood and lymphatic system disorders Lymphopenia	36.2% 29/80 • Number of events 73 • Adverse events were collected from each participant's on-study date through 4 years after completion of therapy.
Infections and infestations Febrile neutropenia	10.0% 8/80 • Number of events 11 • Adverse events were collected from each participant's on-study date through 4 years after completion of therapy.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	5.0% 4/80 • Number of events 6 • Adverse events were collected from each participant's on-study date through 4 years after completion of therapy.

Additional Information

Jamie Flerlage, MD

St. Jude Children's Research Hospital

Phone: 901-595-0392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
Publication restrictions are in place

Restriction type: OTHER