Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children >/= to 8 Months and <3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Study
I. To determine if the proposed treatment for children >= 8.0 months and < 3 years of age at
registration with non-metastatic (M0) medulloblastoma is more effective than the combined
treatments given to children of the same age and extent of disease on POG 9233, as measured
by event-free survival (EFS) rates.
I. To assess the feasibility and safety of the planned use of second look surgery and focal
conformal radiation therapy following chemotherapy. II. To determine the acute and chronic
toxicities associated with the above treatment regimens.
III. To describe the neuropsychological and neuroendocrine effects of this systemic
chemotherapy, surgery, and local, conformal radiation. IV. To determine the feasibility and
validity of a centralized telephone interview based data collection method for
neuropsychological evaluations. V. To determine the incidence of atypical teratoid/rhabdoid
tumor (AT/RT) in children enrolled on this study.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free survival rate
Children's Oncology Group
United States: Institutional Review Board
|Children's Oncology Group||Arcadia, California 91006-3776|