Clinical trial Recruiting at 54 sites Phase 3 Interventional Ages 18 and up

Temporally-Modulated Pulsed Radiation Therapy plus TMZ for MGMT-Unmethylated Glioblastoma

Official title: A Randomized Phase III Study Comparing Temporally-Modulated Pulsed Radiation Therapy (TMPRT) Versus Standard Radiation Therapy With Temozolomide for Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma

Run by NRG Oncology · NCT07452458 · Data updated 2026-11-12

This study tests whether temporally-modulated pulsed radiation therapy plus temozolomide improves outcomes for people with newly diagnosed MGMT-unmethylated, IDH-wildtype glioblastoma.

More Glioblastoma, IDH-wildtype trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment398 (estimated)
SponsorNRG Oncology
Academic / other
Drugs / interventionschemotherapy, radiation
Locations54 sites (Irvine, California and 53 other locations)
StatusRecruiting
StartedJuly 16, 2026
Main results expectedJanuary 15, 2030
Study endsJuly 15, 2035
Registry record updatedSeptember 10, 2026
Trial IDNCT07452458 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with newly diagnosed IDH-wildtype, MGMT-unmethylated glioblastoma who have had surgical resection and can provide tumor tissue for central review.

Probably not a fit

Patients with contraindications to radiation or temozolomide, inability to undergo MRI, or who do not meet surgical/tissue requirements may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares temporally-modulated pulsed radiation therapy (TMPRT) with standard radiation therapy in combination with temozolomide for newly diagnosed MGMT-unmethylated glioblastoma. Participants have undergone surgical resection and consent to central tissue review for MGMT status. Primary goals are to see if TMPRT can delay neurocognitive function failure compared with standard RT plus TMZ, with secondary aims including overall survival, progression-free survival, quality of life, cognitive function, frailty progression, and toxicity. Exploratory aims examine broader functional and psychosocial QoL effects. Biospecimen collection and advanced imaging are part of the protocol to support correlative analyses.

Why it matters

Potential benefit: If successful, TMPRT could prolong neurocognitive function and survival while preserving quality of life for MGMT-unmethylated GBM patients.

How similar studies have gone: Prior research in MGMT-unmethylated GBM has had limited success; this trial explores a novel TMPRT approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* PRIOR TO STEP 1 REGISTRATION:
* No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered).
* Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H\&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis. Note that tissue for central pathology review and central MGMT assessment must be shipped to the New York University (NYU) Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 30. If tissue cannot be shipped by postoperative calendar day 30, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 8 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be completed within 10 business days of receipt of tissue. Results will be entered by the central lab directly into Rave. Note: In the event of an additional tumor resection(s), tissue must be shipped within 30 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection.
* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to Step 1 registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
* No known leptomeningeal disease or metastatic disease outside the brain.
* Age ≥ 18
* Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.
* Karnofsky Performance Status ≥ 70
* Hemoglobin ≥ 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 10.0 g/dl is acceptable)
* Leukocytes ≥ 2,000/mm\^3 OR absolute neutrophil count ≥ 1,500/mm\^3
* Platelets ≥ 100,000/mm\^3
* Creatinine clearance (CrCl) ≥ 50 mL/min
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \[SGPT\]) ≤ 3 x ULN
* No prior cranial radiation therapy that would result in overlap of radiation therapy fields.
* No previous therapy for GBM except surgery, laser interstitial thermal therapy (LITT) or Gliadel wafer.

  * Note: 5-aminolevulinic acid (ALA)-mediated fluorescence-guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent.
* No history of unstable angina requiring hospitalization in the last 3 months
* No history of myocardial infarction within the last 3 months
* New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
* No active infection currently requiring IV antibiotic management
* No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy
* No movement disorder that could impede ability to lie still with an immobilization mask for approximately 40 minutes
* No significant sensory deficits (i.e., blindness, mutism) that would prohibit participation of NCF testing
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to temozolomide
* PRIOR TO STEP 2 REGISTRATION:
* The following baseline neurocognitive tests must be completed within 28 days prior to Step 2 registration: (Hopkins Verbal Learning Test - Revised \[HVLT-R\], Trail Making Test \[TMT\], Controlled Oral Word Association \[COWA\]). The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. The following scores must be obtained for patient eligibility: HVLT-R Total Recall \> 5, HVLT-R Delayed Recall \> 3, HVLT-R Delayed Recognition \> -10, TMT Part A . 2738, TMT Part B . 3724, COWA . 12. Central review of the Neurocognitive tests will be completed in Rave within 3 business days after the upload is completed. Users with the Rave clinical research associate (CRA) role will be able to view the results in Rave. The CRA must confirm that the results are available and meet eligibility requirements prior to proceeding with Step 2 Registration.

  * NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
  * Note: Patients whose neurocognitive test scores do not meet the criteria above will not be eligible for the study and will be reported as ineligible due to "Failure to meet Neurocognitive testing criteria" on Step 2 registration.
* Pathology proven diagnosis of IDH-wildtype glioblastoma with unmethylated MGMT promoter confirmed by central pathology review. IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e. IDH-wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at Step 2.)

  * Central pathology review will generally be completed within 10 business days of receipt of the tissue. Users with the Rave CRA role will be able to view the results in Rave. It must be confirmed that the results are available and meet eligibility requirements prior to proceeding with Step 2 Registration.
  * Note: Patients with tissue that is insufficient or inadequate for analysis, has failed MGMT testing, or has indeterminate or methylated MGMT promoter are excluded and will be reported as a "central pathology review failure" on step 2 registration.

Where it's running

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
    Irvine, California, United States
    Recruiting
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California, United States
    Recruiting
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California, United States
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, United States
    Recruiting
  • Saint Mary's Hospital and Regional Medical Center
    Grand Junction, Colorado, United States
    Recruiting
  • Alton Memorial Hospital
    Alton, Illinois, United States
    Recruiting
Show 44 more locations
  • Decatur Memorial Hospital
    Decatur, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Kishwaukee
    DeKalb, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois, United States
    Recruiting
  • Cancer Care Center of O'Fallon
    O'Fallon, Illinois, United States
    Recruiting
  • HSHS Saint Elizabeth's Hospital
    O'Fallon, Illinois, United States
    Recruiting
  • Memorial Hospital East
    Shiloh, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic
    Ankeny, Iowa, United States
    Recruiting
  • Saint Anthony Regional Hospital
    Carroll, Iowa, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
    Clive, Iowa, United States
    Recruiting
  • Iowa Methodist Medical Center
    Des Moines, Iowa, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic
    Des Moines, Iowa, United States
    Recruiting
  • Broadlawns Medical Center
    Des Moines, Iowa, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Laurel Clinic
    Des Moines, Iowa, United States
    Recruiting
  • UI Healthcare Mission Cancer and Blood - Pella
    Pella, Iowa, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Waukee Clinic
    Waukee, Iowa, United States
    Recruiting
  • University of Kansas Cancer Center
    Kansas City, Kansas, United States
    Recruiting
  • University of Kansas Cancer Center-Overland Park
    Overland Park, Kansas, United States
    Recruiting
  • University of Kansas Hospital-Westwood Cancer Center
    Westwood, Kansas, United States
    Recruiting
  • Maryland Proton Treatment Center
    Baltimore, Maryland, United States
    Recruiting
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland, United States
    Recruiting
  • UM Upper Chesapeake Medical Center
    Bel Air, Maryland, United States
    Recruiting
  • UM Baltimore Washington Medical Center/Tate Cancer Center
    Glen Burnie, Maryland, United States
    Recruiting
  • Siteman Cancer Center at Saint Peters Hospital
    City of Saint Peters, Missouri, United States
    Recruiting
  • MU Health - University Hospital/Ellis Fischel Cancer Center
    Columbia, Missouri, United States
    Recruiting
  • Siteman Cancer Center at West County Hospital
    Creve Coeur, Missouri, United States
    Recruiting
  • University of Kansas Cancer Center - Briarcliff
    Kansas City, Missouri, United States
    Recruiting
  • University of Kansas Cancer Center - North
    Kansas City, Missouri, United States
    Recruiting
  • University of Kansas Cancer Center - Lee's Summit
    Lee's Summit, Missouri, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting
  • Siteman Cancer Center-South County
    St Louis, Missouri, United States
    Recruiting
  • Siteman Cancer Center at Christian Hospital
    St Louis, Missouri, United States
    Recruiting
  • Renown Regional Medical Center
    Reno, Nevada, United States
    Recruiting
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    New York, New York, United States
    Recruiting
  • Montefiore Medical Center-Einstein Campus
    The Bronx, New York, United States
    Recruiting
  • Montefiore Medical Center-Weiler Hospital
    The Bronx, New York, United States
    Recruiting
  • Montefiore Medical Center - Moses Campus
    The Bronx, New York, United States
    Recruiting
  • Case Western Reserve University
    Cleveland, Ohio, United States
    Recruiting
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma, United States
    Recruiting
  • ThedaCare Regional Cancer Center
    Appleton, Wisconsin, United States
    Recruiting
  • University of Wisconsin Carbone Cancer Center - Johnson Creek
    Johnson Creek, Wisconsin, United States
    Recruiting
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
    Madison, Wisconsin, United States
    Recruiting
  • University of Wisconsin Carbone Cancer Center - University Hospital
    Madison, Wisconsin, United States
    Recruiting
  • Froedtert Menomonee Falls Hospital
    Menomonee Falls, Wisconsin, United States
    Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Jiayi Huang — NRG Oncology

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.