|Closed||Brain Cancer; Glioma; Medulloblastoma; Primitive Neuroectodermal Tumor (PNET); Solid Tumors||Phase III||
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.
|Ages Eligible for Study:||3 Years to 21 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
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
- 3 to 21 at diagnosis
- Karnofsky 50-100% (> 16 years of age) OR
- Lansky 30-100% (≤ 16 years of age)
- Not specified
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3 (transfusion independent)
- Hemoglobin > 10 g/dL (transfusions allowed)
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST or ALT < 1.5 times ULN
- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.