Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Status: Recruiting
Phase: Phase 3
Diagnosis: Pediatric Brain Tumor
NCT ID: NCT00085735
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 04-235
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy combined with chemotherapy after surgery is more effective than reduced-dose craniospinal (head and spine) radiation therapy plus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boost radiation therapy combined with chemotherapy in treating medulloblastoma. PURPOSE: This randomized phase III trial is studying standard-dose radiation therapy to see how well it works compared to reduced-dose craniospinal radiation therapy AND posterior fossa boost radiation therapy to see how well it works compared to tumor bed boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma.
Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston, Massachusetts General Hospital
Overall PI:
Susan Chi, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
Eligibility Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 3 to 21 at diagnosis
Performance status
- Karnofsky 50-100% (> 16 years of age) OR
- Lansky 30-100% (≤ 16 years of age)
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3 (transfusion independent)
- Hemoglobin > 10 g/dL (transfusions allowed)
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST or ALT < 1.5 times ULN
Renal
- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Prior corticosteroids allowed
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics