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Radiation Therapy

Proton Beam vs IMRT for Brain Cancer

Phase 2

Waitlist Available

Led By David Grosshans

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Only English speaking patients are eligible to participate as the cognitive and quality of life assessments are available only in English

Documentation from the enrolling site confirming the presence of IDH mutation and 1p/19q status; the provided information must document assays performed in CLIA-approved laboratories

Must not have

Patients with infra-tentorial tumors are not eligible

The use of memantine during or following radiation is NOT allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying proton beam radiation therapy and intensity-modulated radiation therapy to see how well they work in preserving brain function in patients with IDH mutant grade II or III glioma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, fatigue, headaches, hair loss around the treated area, nausea, hearing changes due to ear inflammation from radiation exposure. Rarely there might be more serious risks like memory problems or other cognitive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English and can complete assessments in it.

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My tests confirm I have an IDH mutation and my 1p/19q status is known.

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I can provide a sample of my tumor for review.

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I can care for myself but may not be able to do active work.

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My brain tumor is IDH-mutant and graded II or III.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not using memantine during or after radiation treatment.

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I do not have a severe lung condition that requires hospitalization or would stop me from receiving the study treatment.

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I have severe kidney disease requiring or recommended to have dialysis.

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I have had chemotherapy or radiotherapy for a brain tumor before.

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My diagnosis is either glioblastoma or pilocytic astrocytoma.

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I will only be using temozolomide chemotherapy with my radiation treatment.

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I have a serious heart rhythm problem that is not well-controlled.

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I haven't had serious wounds, ulcers, fractures, or major surgeries in the last 28 days, except for a specific brain surgery.

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I am currently on IV antibiotics for a bacterial or fungal infection.

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I have had radiation therapy to my head or neck before.

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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognition

Secondary study objectives

Change in quality of life as measured by the LASA scale

Change in symptoms as measured by MDASI-BT

Cognition as measured by COWA

+6 more

Other study objectives

Assessment of dose-response relationships

Assessment of tumor molecular status

Side effects data

From 2020 Phase 2 trial • 35 Patients • NCT02073968

71%

Cough

69%

Dysphagia

54%

Dermatitis

40%

Anorexia

23%

Constipation

11%

Dehydration

Pneumonitis

Fatigue

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (proton beam radiation therapy, temozolomide)Experimental Treatment2 Interventions

Patients undergo proton beam radiation therapy QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 4 weeks 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.

Group II: Arm I (photon-based IMRT, temozolomide)Active Control2 Interventions

Patients undergo photon-based IMRT QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 4 weeks 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

Temozolomide

2010

Completed Phase 3

~1880