COG ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

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COG ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

1. To determine the event free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with post-operative conformal radiation therapy (cRT) and then randomized to receive or not receive four cycles of post radiation maintenance chemotherapy with vincristine, cisplatin, etoposide and cyclophosphamide (VCEC).

2. To estimate the EFS and OS of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by a) post-operative induction chemotherapy or by b) second surgery who will then be non-randomly assigned to cRT followed by four cycles of maintenance chemotherapy (VCEC)

3. To further evaluate the EFS and OS of children with supratentorial classic ependymoma who achieve a complete resection at first or second resection or children who achieve a CR to short course induction chemotherapy following first surgery.

Protocol Number111003
Principal InvestigatorRichard Drachtman
PhasePhase III
ScopeNational
Applicable Disease SitesBrain and Nervous System
Therapies InvolvedRadiotherapy
Chemotherapy multiple agents systemic
Drugs InvolvedCYCLOPHOSPHAMIDE
VINCRISTINE
CARBOPLATIN
ETOPOSIDE
FILGRASTIM
Participating InstitutionsRutgers Cancer Institute of New Jersey
Robert Wood Johnson Medical School
Robert Wood Johnson University Hospital in New Brunswick

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.