Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00085735 : Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
PhasePhase 3
AgesMin: 3 Years Max: 21 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00085735      |      Link to official Clinicaltrials.gov listing
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