Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET
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ClinicalTrials.gov Identifier: NCT00392327 |
Recruitment Status :
Active, not recruiting
First Posted : October 26, 2006
Results First Posted : August 7, 2020
Last Update Posted : August 7, 2020
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Anaplastic Medulloblastoma Medulloblastoma |
Interventions |
Drug: Carboplatin Drug: Cisplatin Drug: Cyclophosphamide Biological: Filgrastim Drug: Isotretinoin Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Radiation: Radiation Therapy Drug: Vincristine Sulfate |
Enrollment | 379 |
Participant Flow
Recruitment Details | Patients (Pts) 3-21 yrs were recruited at COG institutions.The first pt was enrolled 5/23/2007, and the last pt was enrolled 4/9/2018.The study was initially open to medulloblastoma and supratentorial primitive neuroectodermal tumor (SPNET) pts, but closed for SPNET pts as of amendment #2.All pts were off treatment at the time of results reporting. |
Pre-assignment Details | Participants received standard therapy consisting of surgery, radiation and chemotherapy. A subset of patients was randomly assigned to receive carboplatin. A second randomization was used to randomly assign patients to receive isotretinoin. Of note, the isotretinoin randomization was stopped early due to futility. |
Arm/Group Title | Regimen A (Medulloblastoma Patients) | Regimen B (Medulloblastoma Patients) | Regimen C (Medulloblastoma Patients) | Regimen D (Medulloblastoma Patients) | Regimen A (SPNET Patients) | Regimen B (SPNET Patients) | Regimen C (SPNET Patients) | Regimen D (SPNET Patients) |
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Medulloblastoma patients who received regimen A (no carboplatin / no isotretinoin) | Medulloblastoma patients who received regimen B (carboplatin / no isotretinoin) | Medulloblastoma patients who received regimen C (no carboplatin / isotretinoin) | Medulloblastoma patients who received regimen D (carboplatin / isotretinoin) | SPNET patients who received regimen A (no carboplatin / no isotretinoin) | SPNET patients who received regimen B (carboplatin / no isotretinoin) | SPNET patients who received regimen C (no carboplatin / isotretinoin) | SPNET patients who received regimen D (carboplatin / isotretinoin) |
Period Title: Overall Study | ||||||||
Started | 87 | 93 | 56 | 58 | 23 | 19 | 21 | 22 |
Completed | 72 | 74 | 36 | 42 | 20 | 14 | 12 | 11 |
Not Completed | 15 | 19 | 20 | 16 | 3 | 5 | 9 | 11 |
Reason Not Completed | ||||||||
Death | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Lack of Efficacy | 8 | 8 | 9 | 6 | 3 | 3 | 3 | 3 |
Physician Decision | 3 | 5 | 2 | 2 | 0 | 1 | 5 | 3 |
Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 3 | 2 | 4 | 6 | 0 | 1 | 1 | 5 |
Ineligible | 0 | 4 | 3 | 2 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Regimen A (Medulloblastoma Patients) | Regimen B (Medulloblastoma Patients) | Regimen C (Medulloblastoma Patients) | Regimen D (Medulloblastoma Patients) | Regimen A (SPNET Patients) | Regimen B (SPNET Patients) | Regimen C (SPNET Patients) | Regimen D (SPNET Patients) | Total | |
---|---|---|---|---|---|---|---|---|---|---|
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Medulloblastoma patients who received regimen A (no carboplatin / no isotretinoin) | Medulloblastoma patients who received regimen B (carboplatin / no isotretinoin) | Medulloblastoma patients who received regimen C (no carboplatin / isotretinoin) | Medulloblastoma patients who received regimen D (carboplatin / isotretinoin) | SPNET patients who received regimen A (no carboplatin / no isotretinoin) | SPNET patients who received regimen B (carboplatin / no isotretinoin) | SPNET patients who received regimen C (no carboplatin / isotretinoin) | SPNET patients who received regimen D (carboplatin / isotretinoin) | Total of all reporting groups | |
Overall Number of Baseline Participants | 87 | 89 | 53 | 56 | 23 | 19 | 21 | 22 | 370 | |
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Only eligible patients were included in the baseline characteristics results. For example, of the 93 Regimen B medulloblastoma patients, 4 were ineligible (see patient flow) and excluded from baseline measures reporting leaving 89 eligible regimen B medulloblastoma patients.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 87 participants | 89 participants | 53 participants | 56 participants | 23 participants | 19 participants | 21 participants | 22 participants | 370 participants | |
<=18 years |
86 98.9%
|
88 98.9%
|
51 96.2%
|
55 98.2%
|
23 100.0%
|
19 100.0%
|
21 100.0%
|
22 100.0%
|
365 98.6%
|
|
Between 18 and 65 years |
1 1.1%
|
1 1.1%
|
2 3.8%
|
1 1.8%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
5 1.4%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Median (Full Range) Unit of measure: Years |
||||||||||
Number Analyzed | 87 participants | 89 participants | 53 participants | 56 participants | 23 participants | 19 participants | 21 participants | 22 participants | 370 participants | |
8.2
(3.5 to 19.2)
|
8.8
(3.5 to 21.2)
|
9.1
(3.3 to 20.1)
|
9
(3.4 to 19.9)
|
10.7
(3.1 to 18.1)
|
9.4
(3.5 to 16.9)
|
8.9
(3.1 to 17.9)
|
10.3
(3.0 to 17.6)
|
8.8
(3.0 to 21.2)
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 87 participants | 89 participants | 53 participants | 56 participants | 23 participants | 19 participants | 21 participants | 22 participants | 370 participants | |
Female |
22 25.3%
|
29 32.6%
|
15 28.3%
|
21 37.5%
|
13 56.5%
|
10 52.6%
|
12 57.1%
|
12 54.5%
|
134 36.2%
|
|
Male |
65 74.7%
|
60 67.4%
|
38 71.7%
|
35 62.5%
|
10 43.5%
|
9 47.4%
|
9 42.9%
|
10 45.5%
|
236 63.8%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 87 participants | 89 participants | 53 participants | 56 participants | 23 participants | 19 participants | 21 participants | 22 participants | 370 participants | |
Hispanic or Latino |
11 12.6%
|
8 9.0%
|
10 18.9%
|
13 23.2%
|
3 13.0%
|
4 21.1%
|
2 9.5%
|
2 9.1%
|
53 14.3%
|
|
Not Hispanic or Latino |
75 86.2%
|
79 88.8%
|
41 77.4%
|
42 75.0%
|
20 87.0%
|
15 78.9%
|
18 85.7%
|
19 86.4%
|
309 83.5%
|
|
Unknown or Not Reported |
1 1.1%
|
2 2.2%
|
2 3.8%
|
1 1.8%
|
0 0.0%
|
0 0.0%
|
1 4.8%
|
1 4.5%
|
8 2.2%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 87 participants | 89 participants | 53 participants | 56 participants | 23 participants | 19 participants | 21 participants | 22 participants | 370 participants | |
American Indian or Alaska Native |
0 0.0%
|
1 1.1%
|
1 1.9%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 4.8%
|
0 0.0%
|
3 0.8%
|
|
Asian |
1 1.1%
|
4 4.5%
|
3 5.7%
|
1 1.8%
|
0 0.0%
|
2 10.5%
|
3 14.3%
|
0 0.0%
|
14 3.8%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
12 13.8%
|
7 7.9%
|
5 9.4%
|
0 0.0%
|
9 39.1%
|
2 10.5%
|
3 14.3%
|
8 36.4%
|
46 12.4%
|
|
White |
63 72.4%
|
69 77.5%
|
38 71.7%
|
49 87.5%
|
13 56.5%
|
13 68.4%
|
10 47.6%
|
12 54.5%
|
267 72.2%
|
|
More than one race |
1 1.1%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 0.3%
|
|
Unknown or Not Reported |
10 11.5%
|
8 9.0%
|
6 11.3%
|
6 10.7%
|
1 4.3%
|
2 10.5%
|
4 19.0%
|
2 9.1%
|
39 10.5%
|
Outcome Measures
Adverse Events