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Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Primary Goal: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide (RT + TMZ → TMZ) (ARM B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT → PCV) (ARM A). Secondary Goals: Time to Progression To determine whether patients who receive RT + TMZ → TMZ have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT → PCV). Correlation between exploratory biomarkers and survival To determine whether there is a difference in survival based on t(1;19)(q10,p10) translocation status and MGMT promoter hypermethylation status. Descriptive Comparisons of Additional Secondary Endpoints To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life. Descriptive Comparisons of Additional Secondary Endpoints To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life. Neurocognitive and Quality of Life Effects To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints. Banking of Biospecimens and Neuroimaging Studies To store blood products (i.e., plasma, DNA, and buffy coat), tumor tissue and MRI/CT images for future scientific investigations.

Primary Goal: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide (RT + TMZ → TMZ) (ARM B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT → PCV) (ARM A). Secondary Goals: Time to Progression To determine whether patients who receive RT + TMZ → TMZ have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT → PCV). Correlation between exploratory biomarkers and survival To determine whether there is a difference in survival based on t(1;19)(q10,p10) translocation status and MGMT promoter hypermethylation status. Descriptive Comparisons of Additional Secondary Endpoints To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life. Descriptive Comparisons of Additional Secondary Endpoints To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life. Neurocognitive and Quality of Life Effects To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints. Banking of Biospecimens and Neuroimaging Studies To store blood products (i.e., plasma, DNA, and buffy coat), tumor tissue and MRI/CT images for future scientific investigations.