Proton Beam vs IMRT for Brain Cancer

Recruiting in Palo Alto (17 mi)

+34 other locations

Overseen byDavid R Grosshans

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.

Eligibility Criteria

This trial is for English-speaking adults with a specific brain tumor (IDH mutant grade II or III glioma). They must be in good physical condition, have certain blood counts and organ functions within normal ranges, and have had recent MR imaging. Patients who've had prior brain radiation, severe psychiatric diseases affecting cognition, or are severely immunocompromised can't participate.

Inclusion Criteria

I speak English and can complete assessments in it.

I must have a detailed MRI with contrast for my treatment planning.

I have financial approval for proton therapy before the next treatment phase.

+14 more

Exclusion Criteria

My cancer is not located in the lower part of my brain.

I am not using memantine during or after radiation treatment.

I was hospitalized for heart failure that is moderately severe or worse in the last year.

+22 more

Participant Groups

The study compares two types of advanced radiation therapy: Proton Beam Radiation Therapy and Intensity-Modulated Radiation Therapy (IMRT), along with Temozolomide chemotherapy. It aims to see which method better preserves brain function while treating the tumor effectively.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (proton beam radiation therapy, temozolomide)Experimental Treatment7 Interventions

Patients undergo proton beam radiation therapy QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 28 days after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity. Patients undergo MRI and collection of blood samples throughout the trial.

Group II: Arm I (photon-based IMRT, temozolomide)Active Control7 Interventions

Patients undergo photon-based IMRT QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 28 days after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity. Patients undergo MRI and collection of blood samples throughout the trial.