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Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

Primary To determine whether the addition of bevacizumab to temozolomide and radiation improves efficacy as measured by progression-free and/or overall survival. Secondary To determine whether the tumor molecular profile conferring a mesenchymal/angiogenic phenotype is associated with a selective increase in benefit, as measured by either overall survival or progression-free survival, from the addition of bevacizumab. To compare and record the toxicities of the conventional and bevacizumab-containing regimens. Tertiary (10/25/11) The primary focus is to determine the differential acute effects associated with the addition of bevacizumab to temozolomide and radiation, as compared to the conventional arm, on measures of neurocognitive function, health-related quality of life, and symptoms during radiation and across the longitudinal progression-free interval. To determine the relationship of neurocognitive function, health-related quality of life, and symptoms, with progression-free and overall survival. To determine the association between tumor molecular profile (i.e., mesenchymal/angiogenic phenotype and proneural phenotype) and neurocognitive function, health-related quality of life, and symptoms. To describe the association between health-related quality of life as measured by the EORTC-QL30/BCM20 and mean symptom severity as measured by the MDASI-BT in patients enrolled in this study. To evaluate the relationship between self-reported neurocognitive function and objectively measured tests of NCF.

Primary To determine whether the addition of bevacizumab to temozolomide and radiation improves efficacy as measured by progression-free and/or overall survival. Secondary To determine whether the tumor molecular profile conferring a mesenchymal/angiogenic phenotype is associated with a selective increase in benefit, as measured by either overall survival or progression-free survival, from the addition of bevacizumab. To compare and record the toxicities of the conventional and bevacizumab-containing regimens. Tertiary (10/25/11) The primary focus is to determine the differential acute effects associated with the addition of bevacizumab to temozolomide and radiation, as compared to the conventional arm, on measures of neurocognitive function, health-related quality of life, and symptoms during radiation and across the longitudinal progression-free interval. To determine the relationship of neurocognitive function, health-related quality of life, and symptoms, with progression-free and overall survival. To determine the association between tumor molecular profile (i.e., mesenchymal/angiogenic phenotype and proneural phenotype) and neurocognitive function, health-related quality of life, and symptoms. To describe the association between health-related quality of life as measured by the EORTC-QL30/BCM20 and mean symptom severity as measured by the MDASI-BT in patients enrolled in this study. To evaluate the relationship between self-reported neurocognitive function and objectively measured tests of NCF.