Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with surgery and radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor.
Brain and Central Nervous System Tumors
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children Greater Than or Equal to 8 Months and Less Than 3 Years With Non-metastatic Medulloblastoma: A Children's Oncology Group Phase III Study|
- Event-free survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Feasibility and safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Neuropsychological and neuroendocrine effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Incidence of atypical teratoid and/or rhabdoid tumor [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2000|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Chemotherapy,surgery, radiation therapy
Safe tumor resection and a 16-week, 4-drug induction chemotherapy regimen of cyclophosphamide, vincristine sulfate, cisplatin, and oral etoposide. Etoposide is given in an oral form. Therapy includes a "second look" conventional surgery following induction chemotherapy To improve local control rates this clinical trial will test the use of conformal radiation therapy and will determine if these techniques can reduce radiation-related side effects. Patients will receive a maintenance phase of chemotherapy, using cyclophosphamide, vincristine sulfate, and the prolonged administration of oral etoposide, to complete one year of therapy
|Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy|
- Compare the efficacy of cyclophosphamide, vincristine, cisplatin, and etoposide followed by second-look surgery and focal conformal radiotherapy vs combination therapy administered on POG 9233 in terms of event-free survival rates in children with nonmetastatic medulloblastoma or posterior fossa primitive neuroectodermal tumor.
- Assess the feasibility and safety of this treatment regimen in these patients.
- Determine the acute and chronic toxicities of this regimen in these patients.
- Determine the neuropsychological and neuroendocrine effects of this regimen in these patients.
- Determine the incidence of atypical teratoid/rhabdoid tumor in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy consisting of vincristine IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses.
After completion of induction chemotherapy, patients with residual disease undergo a second resection.
Within 4 weeks after completion of induction chemotherapy or second resection, patients receive focal conformal radiotherapy daily, 5 days a week, for 6 weeks.
Four weeks after completion of radiotherapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.