Recruiting
Phase 2

Dose-Escalated Hypofractionation

Sponsor:

Brigham and Women's Hospital

Code:

NCT06835803

Conditions

Glioblastoma (GBM)

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Dose-escalated radiation therapy

Standard hypofractionated radiation

Study Details

Brief 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

Conditions

Glioblastoma (GBM)

Study ID

NCT06835803

Start date

Apr 14, 2025

Status verified date

Sep, 2025

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose-escalated hypofractionated radiation over 3 weeks

active comparator: Standard hypofractionated radiation over 3 weeks

Interventions

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

Standard hypofractionated radiation

Standard hypofractionated radiation therapy 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 and Locations

Central contacts

Rifaquat Rahman, MD

617-732-6682rrahman@bwh.harvard.edu

Anurag Saraf, MD

781-624-4700anurag_saraf@dfci.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Rifaquat Rahman, MD

6177325500rrahman@bwh.harvard.edu

Dana-Farber Brigham Cancer Center, Milford Hospital

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

Monica Krishnan, MD

5084883800mkrishnan@bwh.harvard.edu

Dana-Farber Brigham Cancer Center, South Shore Hospital

Recruiting

South Weymouth, Massachusetts, United States, 02190

Contacts

Anurag Saraf, MD

7816244710anurag_saraf@dfci.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

  • glioblastoma
  • elderly glioblastoma
  • hypofractionation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-09-18.