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Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
Primary Objectives
To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients requiring treatment for low-grade gliomas.
To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of patients with low-grade gliomas requiring treatment.
Secondary Objectives
To determine whether combination therapy with temozolomide and radiotherapy improves or maintains cognition and quality of life (QOL) compared to radiotherapy alone.
To compare the severe or worse toxicities (≥ grade 3) of patients receiving radiation therapy alone or radiation therapy plus temozolomide chemotherapy.
To assess the impact of the presence or absence of 1p and 19q deletion on PFS and OS, and to determine the impact of 1p and 19q status on PFS and OS in patients receiving chemotherapy.
To create a tumor and tissue bank, including plasma and germ line DNA, within the ECOG-ACRIN Central Biorepository and Pathology Facility (CBPF).
Primary Objectives
To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients requiring treatment for low-grade gliomas.
To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of patients with low-grade gliomas requiring treatment.
Secondary Objectives
To determine whether combination therapy with temozolomide and radiotherapy improves or maintains cognition and quality of life (QOL) compared to radiotherapy alone.
To compare the severe or worse toxicities (≥ grade 3) of patients receiving radiation therapy alone or radiation therapy plus temozolomide chemotherapy.
To assess the impact of the presence or absence of 1p and 19q deletion on PFS and OS, and to determine the impact of 1p and 19q status on PFS and OS in patients receiving chemotherapy.
To create a tumor and tissue bank, including plasma and germ line DNA, within the ECOG-ACRIN Central Biorepository and Pathology Facility (CBPF).
Recruitment Status
Past Studies