Trial Outcomes & Findings for Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma (NCT NCT00075582)
NCT ID: NCT00075582
Last Updated: 2021-11-19
Results Overview
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
390 participants
Primary outcome timeframe
From enrollment up to 5 years
Results posted on
2021-11-19
Participant Flow
Participant milestones
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
305
|
85
|
|
Overall Study
COMPLETED
|
255
|
50
|
|
Overall Study
NOT COMPLETED
|
50
|
35
|
Reasons for withdrawal
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
8
|
|
Overall Study
Physician Decision
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Ineligible for study
|
36
|
16
|
Baseline Characteristics
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
Baseline characteristics by cohort
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=305 Participants
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
n=85 Participants
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.69 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
5.02 years
STANDARD_DEVIATION 6.78 • n=7 Participants
|
7.11 years
STANDARD_DEVIATION 6.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
217 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
228 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
255 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
269 participants
n=5 Participants
|
77 participants
n=7 Participants
|
346 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=5 Participants
|
5 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment up to 5 yearsPopulation: Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Outcome measures
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=269 Participants
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
n=69 Participants
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry
|
87 Estimated percentage of participants
Interval 82.0 to 91.0
|
67 Estimated percentage of participants
Interval 52.0 to 79.0
|
PRIMARY outcome
Timeframe: From enrollment up to 5 yearsPopulation: All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Outcome measures
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=30 Participants
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry
|
90 Estimated percentage of participants
Interval 72.0 to 97.0
|
—
|
PRIMARY outcome
Timeframe: From enrollment up to 5 yearsPopulation: All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Outcome measures
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=69 Participants
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
|
67 Estimated percentage of participants
Interval 52.0 to 79.0
|
—
|
SECONDARY outcome
Timeframe: From enrollment up to 5 yearsPopulation: Patients who received reduced doses of radiation therapy.
The local failure rate will be estimated using cumulative incidence curves.
Outcome measures
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=52 Participants
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
n=62 Participants
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy
|
0.081 stimated percentage of participants
Interval 0.046 to 0.116
|
0.115 stimated percentage of participants
Interval 0.035 to 0.195
|
SECONDARY outcome
Timeframe: At 13 weeks after inductionPopulation: All eligible Stage I Group III nonorbit primary and stage III group I/II patients
The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.
Outcome measures
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=45 Participants
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Percentage of Patients With Delayed Surgical Procedures
|
0.49 percentage of participants
Interval 0.34 to 0.64
|
—
|
SECONDARY outcome
Timeframe: From enrollment up to 20 weeksPopulation: Patients with Group III vaginal primary tumor
The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection.
Outcome measures
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=5 Participants
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose
|
0 Estimated percentage of participants
|
—
|
Adverse Events
Regimen I (Chemotherapy, Radiotherapy)
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
Regimen II (Chemotherapy, Radiotherapy, Surgery)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=272 participants at risk
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
n=70 participants at risk
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.00%
0/272
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
White blood cell decreased
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
Other adverse events
| Measure |
Regimen I (Chemotherapy, Radiotherapy)
n=272 participants at risk
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
Regimen II (Chemotherapy, Radiotherapy, Surgery)
n=70 participants at risk
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery: Some patients may undergo second-look surgery
dactinomycin: Given IV
cyclophosphamide: Given IV
vincristine sulfate: Given IV
radiation therapy: Undergo radiotherapy
|
|---|---|---|
|
Infections and infestations
Rhinitis infective
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Upper respiratory infection
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
14/272 • Number of events 14
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
12.9%
9/70 • Number of events 9
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.1%
14/272 • Number of events 14
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
10.0%
7/70 • Number of events 7
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Cardiac disorders
Sinus tachycardia
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Eye disorders
Photophobia
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Eye disorders
Watering eyes
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
3/272 • Number of events 3
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Diarrhea
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Flatulence
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Ileus
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
2.9%
2/70 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
3/272 • Number of events 3
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Oral pain
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/272
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
5/272 • Number of events 5
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Facial pain
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Fatigue
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Fever
|
1.8%
5/272 • Number of events 5
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
5.7%
4/70 • Number of events 4
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Non-cardiac chest pain
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Pain
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Catheter related infection
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Conjunctivitis infective
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Infections and infestations - Other
|
1.5%
4/272 • Number of events 4
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
7.1%
5/70 • Number of events 5
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Urinary tract infection
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
2.9%
2/70 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
9/272 • Number of events 9
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
2.9%
2/70 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/272
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
7/272 • Number of events 7
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
4.3%
3/70 • Number of events 3
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Blood bilirubin increased
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Creatinine increased
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Lymphocyte count decreased
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
4.3%
3/70 • Number of events 3
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Neutrophil count decreased
|
15.8%
43/272 • Number of events 43
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
21.4%
15/70 • Number of events 15
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Platelet count decreased
|
3.7%
10/272 • Number of events 10
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Weight loss
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
4.3%
3/70 • Number of events 3
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
White blood cell decreased
|
8.5%
23/272 • Number of events 23
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
14.3%
10/70 • Number of events 10
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/272
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
4/272 • Number of events 4
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
5.7%
4/70 • Number of events 4
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/272
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Headache
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.5%
4/272 • Number of events 4
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.5%
4/272 • Number of events 4
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/272
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
1.1%
3/272 • Number of events 3
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.74%
2/272 • Number of events 2
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.37%
1/272 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
0.00%
0/70
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/272
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
1.4%
1/70 • Number of events 1
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER