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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06835803
Phase
PHASE2
Status
Recruiting
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Conditions

  • Glioblastoma (GBM)

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dose-escalated radiation therapy — RADIATION
    Dose-escalated radiation therapy involves higher doses of radiation therapy each day of treatment over the three week course of radiation therapy
  • Standard hypofractionated radiation — RADIATION
    Standard hypofractionated radiation therapy over 3 weeks

Study Details

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

Key Dates

Start date
Apr 14, 2025
Status verified
Sep 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-escalated hypofractionated radiation over 3 weeks
  • Active Comparator: Standard hypofractionated radiation over 3 weeks

Primary Outcome Measure

Overall survival [ Time Frame: Overall survival from time of enrollment through study completion, an average of 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Rifaquat Rahman, MD
[email protected]
6177325500
Dana-Farber Brigham Cancer Center, Milford HospitalMilfordMassachusetts01757
Monica Krishnan, MD
[email protected]
5084883800
Dana-Farber Brigham Cancer Center, South Shore HospitalSouth WeymouthMassachusetts02190
Anurag Saraf, MD
[email protected]
7816244710

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By research site
Brigham and Women's Hospital· Boston, MADana-Farber Brigham Cancer Center, Milford Hospital· Milford, MADana-Farber Brigham Cancer Center, South Shore Hospital· South Weymouth, MA

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