Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non - 1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.
The goal of the screening consent is to learn if you are eligible to take part in the main research study. The goal of the clinical research study is to learn if giving temozolomide in combination with radiation therapy can help to control anaplastic glioma for a longer time than standard radiation therapy alone. The safety of this combination treatment will also be studied.
Treatment Location: N/A
1. Primary objectives To assess whether concurrent radiotherapy(RT) with daily temozolomide(TMZ) chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma. To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma 2. Secondary objectives To assess whether concurrent and adjuvant temozolomide treatment prolongs progression free survival and neurological deterioration free survival in patients with non-1p/19q deleted anaplastic glioma. To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition. To assess the impact of concurrent and adjuvant temozolomide treatment on the quality of life in patients with non-1p/19q deleted anaplastic glioma.
IRB Review and Approval Date: 06/18/2010
Recruitment Status: Closed
Projected Accrual: N/A
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