Trial Outcomes & Findings for Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma (NCT NCT00105560)
NCT ID: NCT00105560
Last Updated: 2021-12-28
Results Overview
Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
3 Years, 5 years, 7 years, 10 years
Results posted on
2021-12-28
Participant Flow
Participant milestones
| Measure |
Radiation Therapy
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Radiation Therapy
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
Baseline characteristics by cohort
| Measure |
Radiation Therapy
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|
|
Age, Continuous
|
6.6 years
n=5 Participants
|
|
Age, Customized
< 8 Years
|
37 Participants
n=5 Participants
|
|
Age, Customized
≥ 8 Years
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=5 Participants
|
|
Histological Subtype (Dominant Pattern)
Classic
|
45 Participants
n=5 Participants
|
|
Histological Subtype (Dominant Pattern)
Desmoplastic or Nodular Variant
|
6 Participants
n=5 Participants
|
|
Histological Subtype (Dominant Pattern)
Anaplastic or Large Cell Variant
|
8 Participants
n=5 Participants
|
|
Risk Group
Standard
|
39 Participants
n=5 Participants
|
|
Risk Group
Intermediate
|
6 Participants
n=5 Participants
|
|
Risk Group
High
|
14 Participants
n=5 Participants
|
|
Posterior Fossa Syndrome
Yes
|
14 Participants
n=5 Participants
|
|
Posterior Fossa Syndrome
No
|
45 Participants
n=5 Participants
|
|
Ventriculoperitoneal Shunt
Yes
|
12 Participants
n=5 Participants
|
|
Ventriculoperitoneal Shunt
No
|
47 Participants
n=5 Participants
|
|
Enrolled on a Children's Oncology Group Protocol
Yes : ACNS0331
|
8 participants
n=5 Participants
|
|
Enrolled on a Children's Oncology Group Protocol
Yes : ACNS0332
|
2 participants
n=5 Participants
|
|
Enrolled on a Children's Oncology Group Protocol
Yes : ACNS0334
|
1 participants
n=5 Participants
|
|
Enrolled on a Children's Oncology Group Protocol
Yes : A9961
|
1 participants
n=5 Participants
|
|
Enrolled on a Children's Oncology Group Protocol
No
|
47 participants
n=5 Participants
|
|
Boost Field
Tumor Bed Involved Field
|
36 Participants
n=5 Participants
|
|
Boost Field
Posterior Fossa
|
23 Participants
n=5 Participants
|
|
Boost Dose
54 GyRBE
|
57 Participants
n=5 Participants
|
|
Boost Dose
>54 GyRBE
|
2 Participants
n=5 Participants
|
|
Craniospinal Radiation Doses
18-27 GyRBE
|
45 Participants
n=5 Participants
|
|
Craniospinal Radiation Doses
36 GyRBE
|
14 Participants
n=5 Participants
|
|
Hypothalamus Mean Dose (D50)
<40 GyRBE
|
37 Participants
n=5 Participants
|
|
Hypothalamus Mean Dose (D50)
≥40 GyRBE
|
22 Participants
n=5 Participants
|
|
Cochlear Mean Dose to Each Ear (D50)
<30 GyRBE
|
61 Ears
n=5 Participants
|
|
Cochlear Mean Dose to Each Ear (D50)
≥30 GyRBE
|
57 Ears
n=5 Participants
|
|
Cisplatin Cumulative Dose
≤300 mg/m2
|
17 participants
n=5 Participants
|
|
Cisplatin Cumulative Dose
>300 mg/m2
|
34 participants
n=5 Participants
|
|
Use of Photons for <20% radiation dose
Yes
|
6 Participants
n=5 Participants
|
|
Use of Photons for <20% radiation dose
No
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Years, 5 years, 7 years, 10 yearsPopulation: The overall study population after the stated durations of follow-up. Follow-up is ongoing and data is not yet available for the 10 year time point.
Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years.
Outcome measures
| Measure |
Radiation Therapy - 3 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 5 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 7 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|---|---|
|
Cumulative Incidence of Ototoxicity
Cisplatin total dose >300 mg/m2
|
12 percentage of participants
Interval 3.0 to 28.0
|
17 percentage of participants
Interval 5.0 to 35.0
|
17 percentage of participants
Interval 5.0 to 35.0
|
|
Cumulative Incidence of Ototoxicity
All Participants
|
12 percentage of participants
Interval 4.0 to 25.0
|
16 percentage of participants
Interval 6.0 to 29.0
|
16 percentage of participants
Interval 6.0 to 29.0
|
|
Cumulative Incidence of Ototoxicity
Standard Risk
|
15 percentage of participants
Interval 4.0 to 31.0
|
20 percentage of participants
Interval 7.0 to 38.0
|
20 percentage of participants
Interval 7.0 to 38.0
|
|
Cumulative Incidence of Ototoxicity
Intermediate-high risk
|
7 percentage of participants
Interval 0.0 to 29.0
|
7 percentage of participants
Interval 0.0 to 29.0
|
7 percentage of participants
Interval 0.0 to 29.0
|
|
Cumulative Incidence of Ototoxicity
Male
|
4 percentage of participants
Interval 0.0 to 19.0
|
4 percentage of participants
Interval 0.0 to 19.0
|
4 percentage of participants
Interval 0.0 to 19.0
|
|
Cumulative Incidence of Ototoxicity
Female
|
20 percentage of participants
Interval 6.0 to 40.0
|
27 percentage of participants
Interval 9.0 to 49.0
|
27 percentage of participants
Interval 9.0 to 49.0
|
|
Cumulative Incidence of Ototoxicity
<8 years old
|
15 percentage of participants
Interval 5.0 to 32.0
|
20 percentage of participants
Interval 7.0 to 38.0
|
20 percentage of participants
Interval 7.0 to 38.0
|
|
Cumulative Incidence of Ototoxicity
≥8 years old
|
6 percentage of participants
Interval 0.0 to 25.0
|
6 percentage of participants
Interval 0.0 to 25.0
|
6 percentage of participants
Interval 0.0 to 25.0
|
|
Cumulative Incidence of Ototoxicity
Vetriculoperitoneal shunt
|
22 percentage of participants
Interval 3.0 to 53.0
|
22 percentage of participants
Interval 3.0 to 53.0
|
22 percentage of participants
Interval 3.0 to 53.0
|
|
Cumulative Incidence of Ototoxicity
No vetriculoperitoneal shunt
|
10 percentage of participants
Interval 2.0 to 24.0
|
14 percentage of participants
Interval 4.0 to 29.0
|
14 percentage of participants
Interval 4.0 to 29.0
|
|
Cumulative Incidence of Ototoxicity
Cisplatin total dose ≤300 mg/m2
|
18 percentage of participants
Interval 2.0 to 46.0
|
18 percentage of participants
Interval 2.0 to 46.0
|
18 percentage of participants
Interval 2.0 to 46.0
|
SECONDARY outcome
Timeframe: 3 yearsPercentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 3 years of follow-up (as determined by CTCAE 3.0). Incidence is grouped by hormone type and risk group
Outcome measures
| Measure |
Radiation Therapy - 3 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 5 Years Follow-up
n=39 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 7 Years Follow-up
n=20 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|---|---|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years
Any hormone deficit
|
27 percentage of participants
Interval 16.0 to 39.0
|
28 percentage of participants
Interval 15.0 to 43.0
|
25 percentage of participants
Interval 9.0 to 46.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years
Growth hormone deficit
|
22 percentage of participants
Interval 12.0 to 33.0
|
23 percentage of participants
Interval 11.0 to 37.0
|
20 percentage of participants
Interval 6.0 to 40.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years
Thyroid deficiency
|
12 percentage of participants
Interval 5.0 to 22.0
|
10 percentage of participants
Interval 3.0 to 22.0
|
15 percentage of participants
Interval 4.0 to 34.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years
Adrenal or cortisol deficit
|
5 percentage of participants
Interval 1.0 to 13.0
|
3 percentage of participants
Interval 0.0 to 12.0
|
10 percentage of participants
Interval 2.0 to 28.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years
Sex hormone deficit
|
3 percentage of participants
Interval 1.0 to 11.0
|
3 percentage of participants
Interval 0.0 to 12.0
|
5 percentage of participants
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: 5 yearsPercentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 5 years of follow-up (as determined by CTCAE 3.0). Incidence is shown by hormone type and risk group.
Outcome measures
| Measure |
Radiation Therapy - 3 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 5 Years Follow-up
n=39 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 7 Years Follow-up
n=20 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|---|---|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years
Any hormone deficit
|
55 percentage of participants
Interval 41.0 to 67.0
|
58 percentage of participants
Interval 40.0 to 72.0
|
50 percentage of participants
Interval 26.0 to 70.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years
Growth hormone deficit
|
46 percentage of participants
Interval 33.0 to 59.0
|
50 percentage of participants
Interval 33.0 to 65.0
|
40 percentage of participants
Interval 18.0 to 61.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years
Thyroid deficiency
|
21 percentage of participants
Interval 11.0 to 32.0
|
21 percentage of participants
Interval 10.0 to 35.0
|
20 percentage of participants
Interval 6.0 to 40.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years
Adrenal or cortisol deficit
|
9 percentage of participants
Interval 3.0 to 17.0
|
3 percentage of participants
Interval 0.0 to 12.0
|
20 percentage of participants
Interval 6.0 to 40.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years
Sex hormone deficit : Overall study population
|
3 percentage of participants
Interval 1.0 to 11.0
|
3 percentage of participants
Interval 0.0 to 12.0
|
5 percentage of participants
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: 7 yearsPercentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 7 years of follow-up, as determined by CTCAE 3.0. Incidence is shown by hormone type and risk group
Outcome measures
| Measure |
Radiation Therapy - 3 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 5 Years Follow-up
n=39 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 7 Years Follow-up
n=20 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|---|---|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Any hormone deficit
|
63 percentage of participants
Interval 48.0 to 75.0
|
68 percentage of participants
Interval 49.0 to 82.0
|
50 percentage of participants
Interval 26.0 to 70.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Growth hormone deficit
|
55 percentage of participants
Interval 40.0 to 68.0
|
62 percentage of participants
Interval 42.0 to 76.0
|
40 percentage of participants
Interval 18.0 to 61.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Thyroid deficiency
|
26 percentage of participants
Interval 15.0 to 38.0
|
25 percentage of participants
Interval 12.0 to 40.0
|
29 percentage of participants
Interval 9.0 to 53.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Adrenal or cortisol deficit
|
9 percentage of participants
Interval 3.0 to 17.0
|
3 percentage of participants
Interval 0.0 to 12.0
|
20 percentage of participants
Interval 6.0 to 40.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Sex hormone deficit : Overall study population
|
3 percentage of participants
Interval 1.0 to 11.0
|
3 percentage of participants
Interval 0.0 to 12.0
|
5 percentage of participants
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: 3 years, 5 years, 7 yearspercentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) as determined by CTCAE 3.0) at year 3, year 5, and year 7 of follow-up.
Outcome measures
| Measure |
Radiation Therapy - 3 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 5 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 7 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|---|---|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Any hormone deficit
|
27 percentage of participants
Interval 16.0 to 39.0
|
55 percentage of participants
Interval 41.0 to 67.0
|
63 percentage of participants
Interval 48.0 to 75.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Growth hormone deficit
|
22 percentage of participants
Interval 12.0 to 33.0
|
46 percentage of participants
Interval 33.0 to 59.0
|
55 percentage of participants
Interval 40.0 to 68.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Thyroid deficiency
|
12 percentage of participants
Interval 5.0 to 22.0
|
21 percentage of participants
Interval 11.0 to 32.0
|
26 percentage of participants
Interval 15.0 to 38.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Adrenal or cortisol deficit
|
5 percentage of participants
Interval 1.0 to 13.0
|
9 percentage of participants
Interval 3.0 to 17.0
|
9 percentage of participants
Interval 3.0 to 17.0
|
|
Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years
Sex hormone deficit
|
3 percentage of participants
Interval 1.0 to 11.0
|
3 percentage of participants
Interval 1.0 to 11.0
|
3 percentage of participants
Interval 1.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, 5, 7 yearsPopulation: The study participants that were evaluated for changes in neurocognitive outcomes
The mean change per-year in neurocognitive outcomes as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full Scale Intelligence Quotient (FSIQ) of children with the use of four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale that has an average score of 100 and standard deviation of 15 points in the general population, meaning on average 68% of test takers would be within +/- 15 points of 100 and 95% within +/- 30 points. Higher scores represent higher intelligence and lower score represent reduced intelligence. Participants were assessed for changes in score with the use of repeated testing during a median follow-up time of 5.2 years. Repeated measures were taken at baseline, 1, 3, 5, and 7 years or until the participant was not available for evaluation (whichever comes first).
Outcome measures
| Measure |
Radiation Therapy - 3 Years Follow-up
n=54 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 5 Years Follow-up
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 7 Years Follow-up
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|---|---|
|
Mean Change Per-Year in Neurocognitive Outcomes
FSIQ
|
-1.5 units on a scale
Interval -2.1 to -0.9
|
—
|
—
|
|
Mean Change Per-Year in Neurocognitive Outcomes
VCI
|
-1.3 units on a scale
Interval -2.0 to -0.7
|
—
|
—
|
|
Mean Change Per-Year in Neurocognitive Outcomes
PRI
|
-.4 units on a scale
Interval -1.0 to 0.3
|
—
|
—
|
|
Mean Change Per-Year in Neurocognitive Outcomes
Working Memory
|
-0.8 units on a scale
Interval -1.8 to 0.3
|
—
|
—
|
|
Mean Change Per-Year in Neurocognitive Outcomes
Processing speed
|
-2.4 units on a scale
Interval -3.2 to -1.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 years, 7 years, 10 yearsPopulation: Follow-up is ongoing and data is not yet available for the 10 year follow-up time point.
The percentage of participants with progression free survival after five, seven, and ten years in the overall population and by risk and histological group.
Outcome measures
| Measure |
Radiation Therapy - 3 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 5 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 7 Years Follow-up
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|---|---|
|
Progression Free Survival
All Participants
|
80 percentage of participants surviving
Interval 67.0 to 88.0
|
75 percentage of participants surviving
Interval 61.0 to 84.0
|
—
|
|
Progression Free Survival
Standard Risk
|
85 percentage of participants surviving
Interval 69.0 to 93.0
|
81 percentage of participants surviving
Interval 64.0 to 91.0
|
—
|
|
Progression Free Survival
Intermediate-high risk
|
70 percentage of participants surviving
Interval 45.0 to 85.0
|
63 percentage of participants surviving
Interval 37.0 to 81.0
|
—
|
|
Progression Free Survival
Classic or desmoplastic histological subtype
|
80 percentage of participants surviving
Interval 67.0 to 89.0
|
75 percentage of participants surviving
Interval 61.0 to 85.0
|
—
|
|
Progression Free Survival
Anaplastic or large cell histological subtype
|
75 percentage of participants surviving
Interval 31.0 to 93.0
|
75 percentage of participants surviving
Interval 31.0 to 93.0
|
—
|
SECONDARY outcome
Timeframe: 5 years, 7 years, 10 yearsPopulation: Follow-up for the 10 year follow-up is still ongoing and the data is not yet available.
the percentage of participants surviving after five and seven years and at the end of follow-up in the overall population. Survival is shown by risk and histological group.
Outcome measures
| Measure |
Radiation Therapy - 3 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 5 Years Follow-up
n=59 Participants
radiation therapy: Radiation therapy with proton beam to standard doses
|
Radiation Therapy - 7 Years Follow-up
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|---|---|
|
Overall Survival
All Participants
|
83 percentage of participants surviving
Interval 70.0 to 90.0
|
81 percentage of participants surviving
Interval 67.0 to 89.0
|
—
|
|
Overall Survival
Standard Risk
|
86 percentage of participants surviving
Interval 70.0 to 94.0
|
86 percentage of participants surviving
Interval 70.0 to 94.0
|
—
|
|
Overall Survival
Intermediate-high risk
|
75 percentage of participants surviving
Interval 50.0 to 89.0
|
68 percentage of participants surviving
Interval 42.0 to 84.0
|
—
|
|
Overall Survival
Classic or desmoplastic histological subtype
|
84 percentage of participants surviving
Interval 70.0 to 92.0
|
82 percentage of participants surviving
Interval 67.0 to 90.0
|
—
|
|
Overall Survival
Anaplastic or large cell histological subtype
|
75 percentage of participants surviving
Interval 31.0 to 93.0
|
75 percentage of participants surviving
Interval 31.0 to 93.0
|
—
|
Adverse Events
Radiation Therapy
Serious events: 13 serious events
Other events: 59 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Radiation Therapy
n=59 participants at risk
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|
|
Investigations
Neutropenia
|
8.5%
5/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Investigations
Lymphopenia
|
11.9%
7/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Nervous system disorders
Stroke
|
1.7%
1/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Gastrointestinal disorders
esophhagitis
|
1.7%
1/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
Other adverse events
| Measure |
Radiation Therapy
n=59 participants at risk
radiation therapy: Radiation therapy with proton beam to standard doses
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
59/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
General disorders
Fatigue
|
76.3%
45/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Metabolism and nutrition disorders
Anorexia
|
59.3%
35/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Gastrointestinal disorders
Nausea
|
57.6%
34/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Gastrointestinal disorders
Vomiting
|
54.2%
32/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis (scalp or back)
|
35.6%
21/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Nervous system disorders
Headache
|
28.8%
17/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Investigations
Weight Loss
|
16.9%
10/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Blood and lymphatic system disorders
Neutropenia
|
71.2%
42/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
27.1%
16/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.0%
13/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Eye disorders
Cataracts
|
27.1%
16/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Metabolism and nutrition disorders
Obesity
|
11.9%
7/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Nervous system disorders
CNS brainstem injury
|
1.7%
1/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Nervous system disorders
Ataxia
|
47.5%
28/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Psychiatric disorders
Depression
|
6.8%
4/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
8.5%
5/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Musculoskeletal and connective tissue disorders
Truncal muscle weakness
|
1.7%
1/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
|
Nervous system disorders
Nystagmus
|
16.9%
10/59 • Through study completion, median duration of 7 years
Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
|
Additional Information
Dr. Nancy Tarbell, Pediatric Radiation Oncologist
Massachusetts General Hospital
Phone: 617-724-1836
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place