ACNS0121: A Phase II Trial of Conformal Radiation Therapy For Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observations for Completely Resected, Differentiated, Supratentorial Ependymoma
Date Last Modified:
Date First Published: 07/14/2006
Basic Study Information
| Type of Trial | Status of Trial | Age Range | Sponsor of Trial | Protocol ID |
|---|
| Treatment | Active | 13 months to 20 years | COG | ACNS0121 |
Outline
This is a multicenter study.
Patients are stratified according to extent of prior surgical resection. Patients with gross total resection with no visible residual tumor for supratentorial differentiated ependymoma undergo observation.
Patients with supratentorial anaplastic ependymoma or infraterntorial anaplastic or differentiated ependymoma who have undergone gross total resection or near total resection undergo conformal radiotherapy to the brain once daily, 5 days a week for 6-6.5 weeks.
Patients with subtotal resection of tumor of any histology or location 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 8 and continuing until blood counts recover.
Patients then receive a second course of chemotherapy comprising of 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.
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
Projected Accrual
A total of 250-350 patients will be accrued for this study within 5 years
Entry Criteria
Histologically confirmed diagnosis of 1 of the following:
- Intracranial ependymoma
- Differentiated ependymoma or anaplastic ependymoma
- No primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma
- No evidence of noncontiguous spread beyond primary site
- Initial surgical resection within the past 56 days
Patient Characteristics
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
- Able to undergo MRI
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Prior Concurrent Therapy:
Biologic therapy
Chemotherapy
Endocrine therapy
- Prior or concurrent corticosteroids allowed
Radiotherapy
Surgery
- See Disease Characteristics
- More than 1 prior surgery allowed
Other
- No other prior treatment for ependymoma
Who should I contact for more information?
Rebecca Turner, MS
Cincinnati Children's Hospital Medical Center
Division of Hematology / Oncology
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org
