Research Study Summary
ECOG E3F05 Phase III trial to compare the effects, good and/or bad, of adding the chemotherapy pill temozolomide to radiation
ECOG E3F05 Phase III RT + Temodar symptomatic/progress low grade glioma (astro, oligodendro, or oligastro) No pilocytic astro, gangioglioma, pleomorph xanthastro or dysembryoplastic neuorepithel. Supratentorial.
The purpose of this study is to compare the effects, good and/or bad, of adding the chemotherapy pill temozolomide to radiation. Radiation is the commonly used initial intervention for your type of tumor. Temozolomide is an oral, well-tolerated chemotherapy agent that readily crosses the intact blood-brain barrier and has activity against even the most aggressive gliomas. Recent studies have indicated that temozolomide, either as the initial treatment or in tumors that have started to grow following radiation, often helps stop the growth of low-grade gliomas. In this study, you will get either radiation therapy alone or radiation therapy with temozolomide. It is hoped that the combination of two therapies will improve the outcome of treatment of these tumors.
It is known that for a related but more aggressive tumor type, glioblastoma, initial treatment with the combination of radiation and temozolomide is more effective than treatment with radiation alone. The Food and Drug Administration has approved concomitant use with radiation followed by temozolomide alone in the maintenance treatment in newly diagnosed glioblastoma multiforme, but has not yet approved concomitant radiation and temozolomide for your type of tumor. Temozolomide remains an experimental drug for low-grade gliomas.
Patient Inclusion Criteria:
- Age ≥ 18 years
- Mand path submiss hist & 1p/19q del status. Must have >1 unctrolled symptom (ie headache w/mass effect, unctrold seizures post 2 antiepileptics, focal neuro sympt or cognit. Sympt/def) or tumor progression per serial MRIs w/ & w/out contrast. Karnosky PS > 60%.
Patient Exclusion Criteria:
No prev. RT head. Neurocog testing & QOLs.
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