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Phase 2 Study of Radiation Therapy for Glioblastoma in Older Adults

This study is looking at different ways to give radiation therapy to older adults (age 65 and up) with newly diagnosed glioblastoma (GBM), an aggressive brain cancer. Researchers want to see if a higher dose of radiation, called dose-escalated radiation therapy, works better than standard hypofractionated radiation. Both treatments are given over three weeks. The main goal is to see how long people live after treatment. You might be able to join if you have newly diagnosed GBM (WHO grade 4, IDH wild-type) confirmed by a biopsy, are at least 65 years old, and have good functional status. The study plans to enroll 56 participants.

Study design
This is a Phase 2 randomized study involving 56 participants. It compares two different radiation therapy approaches.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure overall survival from the time they join the study through its completion, which is expected to be an average of 1 year.

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NCT06835803

Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial

Recruiting
PHASE2Ages 65+InterventionalTreatment
Brigham and Women's Hospital
~56 participants
Updated 2025-09-18 on ClinicalTrials.gov
What's tested:Dose-escalated radiation therapyStandard hypofractionated radiation

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival
Measured over Overall survival from time of enrollment through study completion, an average of 1 year

Conditions

Glioblastoma (GBM)

Explore related trials

Glioblastoma

Where it's being run

3 sites across 1 states
Massachusetts3

Who to contact

Rifaquat Rahman, MD
[email protected]
617-732-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histological confirmation of WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing). Histopathology must be confirmed by central review.
Newly diagnosed disease, with time elapsed from diagnostic surgery/resection \<8 weeks.
Age ≥ 65 years old at time of glioblastoma diagnosis
Adequate functional status as measured by a ECOG Performance Status 0, 1 or 2, at time of enrollment.
Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 45 days prior to randomization:
Patient may have received corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to randomization.

Exclusion

Participants with recurrent glioma.
Participants with evidence of spinal, leptomeningeal, or more distant disease.
Participants with another active central nervous system malignancies requiring treatment.
Participants with a second invasive malignancy that is A) incompletely treated or requiring ongoing treatment, or B) reasonably anticipated to be associated with a median overall survival of less than 1 year based on population-level data for the specified disease site and stage.
Participants with any other major medical illnesses or psychiatric treatments that in the treating physician's opinion will prevent administration or completion of protocol therapy.
Participants with inadequate mental capacity to provide informed consent
Participants who cannot receive gadolinium
Participants who have undergone prior head and neck or cranial radiation or radiation to any other site previously that would be reasonably anticipated to result in a significant overlap in radiation fields.
Participants who have received systemic or radiosensitizing therapy for a prior head and neck or central nervous system malignancy or any investigational cancer drug for glioblastoma prior to randomization.
Participants who have received or plan to receive any other form of non-surgical local or field treatment overlapping with the anticipated radiation field.
Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) or other acute medical conditions at the time of randomization that would impair the ability of the patient to receive protocol treatment.

What this trial measures

  • Overall survivalOverall survival from time of enrollment through study completion, an average of 1 year

    through study completion, an average of 1 year