Actively Recruiting
Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma (ELITE-GBM): A Phase 2 Hybrid Randomized Trial Leveraging External Data
Led by Brigham and Women's Hospital · Updated on 2025-09-18
56
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying glioblastoma (GBM), a fast-growing brain cancer affecting older adults who have special medical and care needs. This trial explores whether giving higher radiation doses in fewer sessions (dose-escalated hypofractionation) can improve treatment outcomes compared to the standard shorter radiation course. The study is a phase 2 randomized trial aiming to compare safety and effectiveness of these two radiation schedules in people aged 65 and older with newly diagnosed GBM. Participants will receive radiation therapy for three weeks, either as a standard hypofractionated regimen or a dose-escalated hypofractionated regimen with higher daily radiation doses. Both approaches deliver fewer radiation treatments than traditional schedules but differ in daily dose intensity. The study randomly assigns patients to one of these two groups to assess which approach may offer better results. During the trial, participants undergo screening to confirm eligibility, receive radiation treatments, and have follow-up visits to track symptoms and side effects. Researchers will measure overall survival, progression-free survival, treatment-related side effects, quality of life, mood, geriatric assessments, and performance status over up to six months after enrollment. The study will monitor participants for about one year on average to evaluate the effects of the treatments.
CONDITIONS
Brief 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) confirmed by central review
- Newly diagnosed glioblastoma with less than 8 weeks since diagnostic surgery or resection
- Age 65 years or older at diagnosis
- ECOG performance status of 0, 1, or 2 at enrollment
- Adequate blood counts and kidney and liver function within 45 days before 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 distant disease
- Other active central nervous system cancers needing treatment
- Second invasive cancer incompletely treated or expected to shorten survival to less than 1 year
- Major medical or psychiatric conditions preventing treatment or study completion
- Inadequate mental capacity to give informed consent
- Unable to receive gadolinium contrast
- Prior head, neck, or cranial radiation overlapping planned treatment fields
- Previous systemic or radiosensitizing therapy for brain or head and neck cancers
- Planned or prior overlapping local or field treatment
- Serious active infection or acute medical conditions impairing treatment ability at randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive either dose-escalated hypofractionated radiation or standard hypofractionated radiation therapy over a three week period.
Daily visits for radiation therapy over 3 weeks
Duration - Up to 6 months
Participants are monitored for treatment-related toxicity, health-related quality of life, mood symptoms, geriatric assessment, and performance status for up to 6 months after treatment.
Regular follow-up visits up to 6 months
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
A
Anurag Saraf, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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