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Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Not Recruiting
Trial ID: NCT00085735
Purpose
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 radiation therapy works compared to smaller volume boost radiation therapy when
given together with chemotherapy in treating young patients who have undergone surgery for
newly diagnosed standard-risk medulloblastoma. 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 is more
effective than reduced-dose radiation therapy when given together with chemotherapy after
surgery in treating young patients with medulloblastoma.
Official Title
A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
Stanford Investigator(s)
Eligibility
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
Intervention(s):
drug: cyclophosphamide
drug: lomustine
drug: cisplatin
drug: vincristine sulfate
radiation: radiation therapy
radiation: Craniospinal Irradiation
radiation: Involved-Field Radiation Therapy
other: Laboratory Biomarker Analysis
other: Quality-of-Life Assessment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Min Wang
6507364281