Brain radiation showdown: proton vs. photon – which saves your mind?

NCT ID NCT03180502

Disease control Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This study compares two radiation methods—proton beam and photon beam (IMRT)—in 120 people with slow-growing brain tumors (IDH-mutant gliomas). The goal is to see which better preserves memory and thinking over time. Participants are randomly assigned to one type of radiation and tracked for up to 10 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Proton beam radiation therapy and intensity-modulated radiation therapy (photon therapy)
What this could lead to: If successful, this could show that proton therapy better preserves memory and thinking skills in brain tumor patients compared to standard radiation.
What could go wrong: This is a phase 2 trial with only 120 participants, so results may not apply to everyone. The study is active but not recruiting, and long-term outcomes are still being tracked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2018

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION * Tumor tissue must be available for submission for central pathology review * Grade II and III gliomas IDH mutant gliomas including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma * Documentation from the enrolling site confirming the presence of IDH mutation and 1p/19q status; the provided information must document assays performed in clinical laboratory improvement amendments (CLIA)-approved laboratories and be uploaded prior to Step 2 registration * Age \>= 18 * The trial is open to both genders * Only English or French speaking patients are eligible to participate as the cognitive assessments are only available in these languages * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry * History and physical exam, and Karnofsky performance status of \>= 70 within 30 days prior to registration * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 60 days prior to registration) * Platelets \>= 100,000 cells/mm\^3 (within 60 days prior to registration) * Hemoglobin \>= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable) (within 60 days prior to registration) * Bilirubin =\< 1.5 upper limit of normal (ULN) (within 60 days prior to registration) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (within 60 days prior to registration) * Blood urea nitrogen (BUN) \< 30 mg/dl (within 60 days prior to registration) * Serum creatinine \< 1.5 mg/dl (within 60 days prior to registration) * Pre-operative MRI imaging of the brain available for radiation planning * Post-operative MRI imaging with contrast is mandatory obtained for radiation therapy planning; enrolling sites are not mandated although highly encouraged to obtain thin-slice (\< 1.5 mm) 3 dimensional (D) pre and post contrast and axial T2/FLAIR sequences for planning purposes * Patients must be able to swallow capsules * PRIOR TO STEP 2 REGISTRATION * Histologically proven diagnosis of supratentorial, World Health Organization (WHO) grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma, with IDH mutation confirmed by central review * The following baseline neurocognitive assessments must be completed and uploaded prior to Step 2 registration: HVLT-R (recall, delayed recall, and recognition), TMT Parts A and B, and COWA; the neurocognitive assessment will be uploaded into a folder in the NRG Medidata RAVE System for central evaluation; once the upload and scoring of the tools are complete, a notification will be sent within 3 business days to the Research Associate (RA) to proceed to Step 2; in order for the patient to be eligible, at least 5 of the 6 neurocognitive assessments must be able to be scored (i.e. free of any errors) * Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire; these quality of life forms will be required and data entered at step 2 registration * Financial clearance for proton therapy treatment prior step 2 registration * Women of childbearing age must have a negative serum pregnancy test within 14 days prior to step 2 registration Exclusion Criteria: * Definitive clinical or radiologic evidence of metastatic disease; if applicable * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity or cervix are permissible) * Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist * Prior chemotherapy or radiotherapy for any brain tumor * Histologic diagnosis of glioblastoma (WHO grade IV) or pilocytic astrocytoma (WHO grade I) * Definitive evidence of multifocal disease * Planned use of cytotoxic chemotherapy during radiation (only adjuvant temozolomide therapy will be used on this protocol) * Patients with infra-tentorial tumors are not eligible * Prior history of neurologic or psychiatric disease believed to impact cognitive function * The use of memantine during or following radiation is NOT allowed * Severe, active co-morbidity defined as follows: * Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment * Transmural myocardial infarction within the last 6 months prior to registration; evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \>= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration (Note: EKG to be performed only if clinical suspicion of cardiac issue) * New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration * Serious and inadequately controlled arrhythmia at step 2 registration * Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter; acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol * Any other severe immunocompromised condition * Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity * End-stage renal disease (i.e., on dialysis or dialysis has been recommended) * Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy * Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction); note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia * Patients known to have hypersensitivity to dacarbazine (DTIC) are not eligible

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Conditions

The condition(s) this trial relates to.

anaplastic astrocytoma anaplastic oligoastrocytoma anaplastic oligodendroglioma astrocytoma (excluding glioblastoma) diffuse astrocytoma glioma grade III glioma oligoastrocytoma oligodendroglioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anaplastic astrocytoma Anaplastic oligoastrocytoma Anaplastic oligodendroglioma Diffuse astrocytoma GLIOMA Oligoastrocytoma Oligodendroglioma Who grade 3 glioma

Contacts and locations

Locations

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044, United States
Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
FHCC at Northwest Hospital

Seattle, Washington, 98133, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States
MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States
Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern University

Chicago, Illinois, 60611, United States
UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061, United States
UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States
University Hospitals Portage Medical Center

Ravenna, Ohio, 44266, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116, United States
University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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