Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Condition: Untreated Childhood Medulloblastoma
MeSH terms: Medulloblastoma
Intervention: Cisplatin; Craniospinal Irradiation; Cyclophosphamide; Involved-Field Radiation Therapy; Laboratory Biomarker Analysis; Lomustine; Quality-of-Life Assessment; Radiation Therapy; Vincristine Sulfate
Intervention description: Given IV; Undergo craniospinal Irradiation; Given IV; Undergo smaller volume boost (involved-field radiation therapy); Correlative studies; Given orally; Ancillary studies; Undergo standard volume boost (whole posterior fossa radiation therapy); Given IV
Intervention MeSH terms: Cyclophosphamide; Lomustine; Cisplatin; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 549.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No

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 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.
    

Eligibility criteria:

        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