Status:
COMPLETED
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Medulloblastoma
Eligibility:
All Genders
3-21 years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost ra...
Detailed Description
PRIMARY OBJECTIVE: I. To determine whether reducing the craniospinal dose of radiation therapy to 18.00 Gy in children 3-7 years of age does not compromise event-free survival and overall survival as...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed medulloblastoma located in the posterior fossa
- Standard-risk disease
- Minimal volume, non-disseminated disease, defined by the following:
- Residual tumor ≤ 1.5 cm\^2 confirmed by MRI with contrast imaging within 21 days after surgery
- No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following:
- Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery
- Negative cytological examination of CSF after surgery, but before study enrollment
- Brain stem involvement allowed
- Performance status - Karnofsky 50-100% (\> 16 years of age)
- Performance status - Lansky 30-100% (≤ 16 years of age)
- Absolute neutrophil count \> 1,500/uL
- Platelet count \> 100,000/uL (transfusion independent)
- Hemoglobin \> 10 g/dL (transfusions allowed)
- Bilirubin \< 1.5 times upper limit of normal (ULN) for age
- AST or ALT \< 1.5 times ULN for age
- Creatinine clearance OR radioisotope glomerular filtration rate \>= 70 mL/min/1.73m\^2 or a serum creatinine based on age/gender as follows:
- Age Maximum Serum Creatine (mg/dL)
- 1month to \< 6 months male: 0.4 female: 0.4
- 6 months to \<1 year male: 0.5 female: 0.5
- 1 year to \< 2 years male: 0.6 female: 0.6
- 2 to \< 6 years male: 0.8 female: 0.8
- 6 to \< 10 years male: 1 female: 1
- 10 to \< 13 years male: 1.2 female: 1.2
- 13 to \< 16 years male: 1.5 female: 1.4
- \>= 16 years male: 1.7 female: 1.4
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chemotherapy
- Prior corticosteroids allowed
- No prior radiotherapy
Exclusion
Key Trial Info
Start Date :
April 30 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT00085735
Start Date
April 30 2004
End Date
December 31 2024
Last Update
January 14 2025
Active Locations (197)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
4
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719