Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years
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.The main 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).
â?¢Patients must be greater than 12 months of age and less than 21 years of age at the time of study enrollment. â?¢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.â?¢Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible.â?¢Patients with evidence of metastatic disease by MRI or CSF cytology are NOT eligible.â?¢Adequate kidney, liver, bone marrow, and cardiac function.â?¢No prior treatment other than surgical intervention and corticosteroids. Patients are allowed to have had more than one attempt at resection prior to enrollment.â?¢Pregnant female patients are not eligible for this study. Female patients who have had their first period 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.
Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
07/25/2014 04:02 AM