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ACTIVE NOT RECRUITING
NCT03180502
PHASE2

Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Randomized Trial of Proton Vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients With IDH Mutant, Low to Intermediate Grade Gliomas

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2018-01-23

Completion Date

2027-06-01

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

RADIATION

Proton Beam Radiation Therapy

Undergo proton beam radiation therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Temozolomide

Drug

Locations (34)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

Maryland Proton Treatment Center

Baltimore, Maryland, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Case Western Reserve University

Cleveland, Ohio, United States

University Hospitals Parma Medical Center

Parma, Ohio, United States

University Hospitals Portage Medical Center

Ravenna, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

FHCC at Northwest Hospital

Seattle, Washington, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States