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Therapeutic Areas: Oncology | Neurology | Family Medicine
Disease Category: Brain Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

ECOG E3F05 Phase III trial to compare the effects, good and/or bad, of adding the chemotherapy pill temozolomide to radiation

Purpose

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.
  • To Learn more
    Phase

    3

    Gender

    Both Male and Female

    Age

    18 and up

    Overall Status

    Recruiting

    Facility Type

    N/A

    Contact

    Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
    Sherman Health
    1425 North Randall Road
    Elgin, IL 60123
    Phone: 224-783-2907
    Fax: 224-783-3071

    View Map

    Research Center Information: Sherman Health

    If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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    CW ID: 183101

    Date Last Changed: May 5, 2014


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