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RECRUITING
NCT06835803
PHASE2

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-04-14

Completion Date

2029-03-31

Last Updated

2025-09-18

Healthy Volunteers

No

Interventions

RADIATION

Dose-escalated radiation therapy

Dose-escalated radiation therapy involves higher doses of radiation therapy each day of treatment over the three week course of radiation therapy

RADIATION

Standard hypofractionated radiation

Standard hypofractionated radiation therapy over 3 weeks

Locations (3)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Brigham Cancer Center, Milford Hospital

Milford, Massachusetts, United States

Dana-Farber Brigham Cancer Center, South Shore Hospital

South Weymouth, Massachusetts, United States