Enhanced local intensified radiation for older adults with glioblastoma

Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma (ELITE-GBM): A Phase 2 Hybrid Randomized Trial Leveraging External Data

This trial tests whether a higher-dose, short-course (hypofractionated) radiation schedule helps people aged 65 and older with newly diagnosed glioblastoma do better than the standard short-course radiation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 3 sites (Boston, Massachusetts and 2 other locations)
• Trial ID: NCT06835803 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 hybrid randomized trial comparing dose‑escalated hypofractionated radiotherapy to standard hypofractionated radiotherapy in older adults with newly diagnosed glioblastoma. Eligible participants are age 65 or older with histologically confirmed WHO grade 4 (IDH wild-type) glioblastoma, ECOG performance status 0–2, and enrollment within eight weeks of surgery with central pathology review. Radiation will be delivered either at the standard daily hypofractionated dose or at an increased per‑fraction dose over a short course, and participants will be followed for safety, treatment‑related toxicity, and clinical outcomes. The trial is being conducted across academic and community sites affiliated with the lead institution to capture both efficacy and real‑world delivery data.

Who should consider this trial

Good fit: People aged 65 and older with newly diagnosed, centrally confirmed WHO grade 4 (IDH wild-type) glioblastoma, ECOG 0–2, within eight weeks of surgery and with adequate blood, kidney, and liver function are ideal candidates.

Not a fit: Patients with ECOG performance status greater than 2, uncontrolled major medical problems, significant organ dysfunction, or those who do not meet the laboratory or timing requirements are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, dose‑escalated short-course radiation could improve local control or survival while keeping treatment duration short for older patients.

How similar studies have performed: Prior studies have shown hypofractionation is feasible in older adults, but dose‑escalated hypofractionated approaches remain relatively novel and unproven.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts and 2 other locations

• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• Dana-Farber Brigham Cancer Center, Milford Hospital — Milford, Massachusetts, United States (Recruiting)
• Dana-Farber Brigham Cancer Center, South Shore Hospital — South Weymouth, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Rifaquat Rahman, MD

Conditions Glioblastoma; glioblastoma; elderly glioblastoma; hypofractionation