Actively Recruiting
Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial
Led by Brigham and Women's Hospital · Updated on 2025-09-18
56
Participants Needed
3
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. To address these challenges, prior work has evaluated the feasibility of hypofractionation, a treatment approach delivering fewer, larger radiation dosages over a shorter time period. Common hypofractionated regimens deliver a lower biologically equivalent radiation dose than the conventional regimens used for younger adults. Whether dose escalated hypofractionation can further improve outcomes in older adults remains unclear. This will be a hybrid randomized control trial comparing the efficacy and safety of dose-escalated and standard hypofractionated radiotherapy among older adults with newly-diagnosed glioblastoma compared to standard three-week course. This research study involves the administration of radiation therapy. Radiation will either be delivered at the standard daily dose or at an increased daily dose over a three weeks course of radiation treatment. Research study procedures will include a screening evaluation to assess eligibility, as well as clinical visits for radiation delivery and to assess symptoms during treatment and at scheduled follow-up times. Participants will be randomly assigned to one of the two arms of the trial: 1. Standard hypofractionated radiation over 3 weeks 2. Dose-escalated hypofractionated radiation over 3 weeks
CONDITIONS
Official Title
Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing), confirmed by central review
- Newly diagnosed disease with less than 8 weeks since diagnostic surgery or resection
- Age 65 years or older at time of glioblastoma diagnosis
- ECOG Performance Status of 0, 1, or 2 at enrollment
- Adequate hematological, renal, and hepatic function as demonstrated by specific laboratory values within 45 days prior to randomization
- Stable or decreasing corticosteroid dose for at least 14 days before randomization
You will not qualify if you...
- Recurrent glioma
- Evidence of spinal, leptomeningeal, or more distant disease
- Other active central nervous system malignancies requiring treatment
- Second invasive malignancy incompletely treated or requiring ongoing treatment, or expected to reduce survival to less than 1 year
- Major medical illnesses or psychiatric treatments preventing protocol therapy
- Inadequate mental capacity to provide informed consent
- Inability to receive gadolinium
- Prior head and neck or cranial radiation overlapping planned radiation fields
- Previous systemic or radiosensitizing therapy for CNS malignancy or investigational glioblastoma drugs prior to randomization
- Planned or received other non-surgical local treatments overlapping radiation fields
- Serious active infection or acute medical conditions impairing protocol treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana-Farber Brigham Cancer Center, Milford Hospital
Milford, Massachusetts, United States, 01757
Actively Recruiting
3
Dana-Farber Brigham Cancer Center, South Shore Hospital
South Weymouth, Massachusetts, United States, 02190
Actively Recruiting
Research Team
R
Rifaquat Rahman, MD
CONTACT
A
Anurag Saraf, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here