NCT00085735
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
PHASE3
ACTIVE_NOT_RECRUITING
NCT00085735
INTERVENTIONAL
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
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.
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
Medulloblastoma
- TREATMENT
-
- Type: DRUG
- Name: Cisplatin
- Description: Given IV
- Arm Group Labels: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
-
- Type: RADIATION
- Name: Craniospinal Irradiation
- Description: Undergo craniospinal Irradiation
- Arm Group Labels: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
-
- Type: DRUG
- Name: Cyclophosphamide
- Description: Given IV
- Arm Group Labels: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
-
- Type: RADIATION
- Name: Involved-Field Radiation Therapy
- Description: Undergo smaller volume boost (involved-field radiation therapy)
- Arm Group Labels: Arm I (3-7 years of age, LDCSI, IFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm V (8-21 years of age, SDCSI, IFRT)
-
- Type: OTHER
- Name: Laboratory Biomarker Analysis
- Description: Correlative studies
- Arm Group Labels: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
-
- Type: DRUG
- Name: Lomustine
- Description: Given orally
- Arm Group Labels: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
-
- Type: OTHER
- Name: Quality-of-Life Assessment
- Description: Ancillary studies
- Arm Group Labels: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
-
- Type: RADIATION
- Name: Radiation Therapy
- Description: Undergo standard volume boost (whole posterior fossa radiation therapy)
- Arm Group Labels: Arm II (3-7 years of age, LDCSI, PFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
-
- Type: DRUG
- Name: Vincristine Sulfate
- Description: Given IV
- Arm Group Labels: Arm I (3-7 years of age, LDCSI, IFRT), Arm II (3-7 years of age, LDCSI, PFRT), Arm III (3-7 years of age, SDCSI, IFRT), Arm IV (3-7 years of age, SDCSI, PFRT), Arm V (8-21 years of age, SDCSI, IFRT), Arm VI (8-21 years of age, SDCSI, PFRT)
- Children's Oncology Group