Title (COG ACNS0831) Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 Years
Principal Investigator Martin Brecher, MD
Study Number 186710
Summary This study proposes to answer the question of whether the administration of maintenance chemotherapy following radiation will improve event free and overall survival or whether it will only result in additional toxicity. Neurologic, neuropsychological and endocrine long-term sequelae of surgery, cRT and maintenance chemotherapy will be assessed. This study will use a comprehensive genetic approach in order to create a molecular classification for ependymoma and to identify the genetic alterations underlying the biological and clinical behavior of various subsets of this tumor.
- Patients must be greater than 12 months of age and less than 21 years of age at the time of study enrollment
- Patients must be newly diagnosed with intracranial ependymoma. Patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above. The diagnosis of intracranial ependymoma must be histologically confirmed. Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible.
- No evidence of non-contiguous spread beyond the primary site as determined by pre or post operative MR imaging of the brain, pre or post operative MR imaging of the spine, and post operative CSF cytology obtained from the lumbar CSF space.
- Patients with evidence of metastatic disease by MRI or CSF cytology are NOT eligible.
- Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients less than or equal to 16 years of age.
- No prior treatment other than surgical intervention and corticosteroids. Patients are allowed to have had more than one attempt at resection prior to enrollment.
- Adequate renal function, adequate liver function, adequate bone marrow function and adequate cardiac function as described in section 3.2.6.
- Pregnant female patients are not eligible for this study. Post-menarchal females may only participate unless a pregnancy test with a negative result had been obtained. Lactating females may not participate unless they have agreed not to breastfeed a child while on this study.
- Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.