Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years
Sandeep Batra, MD
Primary Investigator
Brief description of study
This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma.
Detailed description of study
The purpose of this study is to determine the event-free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with maintenance chemotherapy comprising vincristine sulfate, cisplatin, etoposide, and cyclophosphamide (VCEC) versus observation following post-operative conformal radiotherapy (cRT).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Ependymoma,Children's Cancers,Children's Cancers
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Age: Between 1 Years - 21 Years
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Gender: All
Inclusion Criteria
Patients must be newly diagnosed with histologically confirmed 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
Exclusion Criteria
Patients with evidence of metastatic disease will be excluded
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
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