Can a higher radiation dose help older brain cancer patients live longer?
NCT ID NCT06835803
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a higher daily dose of radiation over three weeks is better than the standard dose for people aged 65 and older with newly diagnosed glioblastoma, an aggressive brain cancer. About 56 participants will be randomly assigned to one of two radiation schedules. The study will compare survival, tumor control, side effects, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy
- What this could lead to
- If successful, this could show that a higher daily radiation dose over three weeks improves survival and tumor control for older adults with glioblastoma.
- What could go wrong
- This is a small early-phase trial (56 participants) and may not prove effective. Higher radiation doses could also increase side effects like brain swelling or fatigue.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 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: Platelet count ≥ 100 x 10\^9/L (100,000 cells/mm\^3) Serum creatinine ≤ 1.5 times the upper limit of normal Total serum bilirubin ≤ 1.5 times the upper limit of normal ALT (SGPT) \< 2.5 times the upper limit of normal and/or AST (SGOT) \< 2.5 times the upper limit of normal -Patient may have received corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to randomization. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Dana-Farber Brigham Cancer Center, Milford Hospital
RECRUITINGMilford, Massachusetts, 01757, United States
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Dana-Farber Brigham Cancer Center, South Shore Hospital
RECRUITINGSouth Weymouth, Massachusetts, 02190, United States
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Other studies related to the condition(s) this trial covers.
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- Can a pill reach the brain and fight tumors?