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

Protocol
11-120
Full Title
Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas (ECOG E3F05)
Purpose

Radiation therapy is the most commonly used initial treatment for low-grade gliomas. The purpose of this study is to determine if adding the drug temozolomide to radiation is more effective than radiation therapy alone in patients with low-grade gliomas that are causing symptoms or are continuing to grow.

Patients will be randomly assigned to receive radiation therapy with or without temozolomide. Temozolomide is approved for treating high-grade gliomas and is taken by mouth. Patients who receive temozolomide will take the medication during the period they are receiving radiation therapy as well as after radiation is completed.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of low-grade glioma (grade 2 astrocytoma, oligodendroglioma, or oligoastrocytoma) that is causing symptoms or continues to grow.
  • Patients may not have had prior radiation therapy to the brain, chemotherapy, or radiosurgery for the brain tumor. Surgery is permitted but must have been completed at least 2 weeks before entering the study.
  • Patients must be age 18 or older. Patients under 40 whose only symptom of low-grade glioma is seizures that are well-controlled on antiepileptic drugs and who have no x-ray evidence of progression may not be eligible to participate.

For more information about this study and to inquire about eligibility, please contact the Brain Tumor Hotline at 212-639-6767.

Disease(s)
Brain Tumors, Primary
Brain Tumors, Primary: Gliomas
Pediatric Brain Tumors: Brain Cancer