Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas

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Study Number:
CTSU E3F05

Topic:
Low Grade Glioma

Principal Investigator:
Pater

Addtional Investigators:
John C Breneman
Rekha Chaudhary
Jessica N Guarnaschelli
Christopher M McPherson
Ronald E Warnick

Ongoing:
Ongoing

Place:
The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center

Overview:

This study is being conducted to compare the effects of adding the chemotherapy agent, temozolomide, to radiation for patients with low grade gliomas, WHO grade II astrocytoma, oligodendroglioma, or oligoastrocytoma. Radiation has been shown to be effective for these tumors. Recent studies have indicated that temozolomide, either as the initial treatment for newly diagnosed tumors or as treatment for progressive tumors that have started to grow despite prior treatments, may help to slow the growth of low grade gliomas. In this study, eligible patients will be randomized into one of two groups. Both groups, will receive 5 ½ weeks of standard fractionated radiation to their tumor. Group 2 will also receive temozolomide during radiation therapy and then monthly for 12 months. Patients will be monitored closely during the study and followed for 15 years following completion of the study.

Qualifications:
Eligible patients must be at least 18 years old and have Symptomatic or Progressive Low Grade Gliomas

Contact:
For more information, please contact Alison Kastl, BS, CCRC, Director of Clinical Trials, at kastla@ucmail.uc.edu or (513) 584-0436.

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