Trial Information

A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma

OBJECTIVES:

- Determine the local control and pattern of failure in children with completely
resected, differentiated, supratentorial localized ependymoma after initial surgical
resection alone.

- Determine the rate of complete resection with second surgery after chemotherapy in
patients with initially incompletely resected localized ependymoma.

- Determine the local control and pattern of failure in patients treated with conformal
radiotherapy.

- Determine the influence of histologic grade on the time to progression in patients
after treatment with conformal radiotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior
surgical resection.

- Group 1 (patients with supratentorial differentiated ependymoma who have undergone
gross total resection and have no visible residual tumor): Patients undergo
observation.

- Group 2 (patients with supratentorial anaplastic ependymoma or infratentorial
anaplastic or differentiated ependymoma who have undergone gross total resection or
near total resection): Patients undergo conformal radiotherapy to the brain once daily
5 days a week for 6-6½ weeks.

- Group 3 (patients with tumor of any histology or location who have undergone subtotal
resection): Patients receive an initial course of chemotherapy comprising vincristine
IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1
hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV
beginning on day 3 and continuing until blood counts recover. Patients then receive a
second course of chemotherapy comprising vincristine IV on days 1 and 8, carboplatin IV
over 1 hour on day 1, and oral etoposide on days 1-21. After completion of
chemotherapy, patients are evaluated for second surgery. Patients who have unresectable
disease undergo conformal radiotherapy. Patients who have resectable disease undergo
second surgery followed by conformal radiotherapy.

Patients are followed every 4 months for 3 years, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 250-350 patients will be accrued for this study within 5
years.