Radiation Therapy + Temozolomide for Brain Tumor

Recruiting in Palo Alto (17 mi)

+167 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eastern Cooperative Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma. PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.

Research Team

David Schiff, MD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for adults with low-grade glioma, a type of brain tumor. Participants must have symptoms like headaches or seizures, show tumor growth on MRIs, or be over 40 years old. They should be in good physical condition and not pregnant. People who only have well-controlled seizures or other specific health issues are excluded.

Inclusion Criteria

Your platelet count is at least 100,000 per cubic millimeter.

Your hematocrit level is equal to or greater than 30%.

Your bilirubin levels in the blood are not more than 2 times the normal limit.

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Exclusion Criteria

I do not have any health conditions that would shorten my life to less than 5 years.

I haven't had treatments like radiation or chemotherapy for my brain tumor.

I have not had radiation therapy to my head that affected my brain.

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Treatment Details

Interventions

3-dimensional conformal radiation therapy (Radiation)
Intensity-modulated radiation therapy (Radiation)
Temozolomide (Alkylating agents)

Trial OverviewThe study is testing if radiation therapy works better alone or combined with temozolomide chemotherapy for treating low-grade glioma. Patients will randomly receive either just high-precision radiation therapy or the same radiation plus temozolomide.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm IIExperimental Treatment3 Interventions

Patients undergo radiotherapy as in arm I and receive concurrent oral temozolomide once daily for 5½ weeks. Beginning 28 days after completion of chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm IActive Control2 Interventions

Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).