ACNS0831: This phase III trial is comparing post-radiation chemotherapy and observation for the treatment of young people with newly diagnosed ependymomasPhase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years

Exclusion

• Patients with evidence of metastatic disease will be excluded; any evidence of non-contiguous spread beyond the primary site as determined by pre or post-operative magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar CSF space (the requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated); CSF cytology from a ventriculostomy or permanent ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative of metastatic disease
• Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible
• No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment
• Pregnant female patients are not eligible for this study
• Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained
• Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
• Lactating females may not participate unless they have agreed not to breastfeed a child while on this study