OncoMatch/Clinical Trials/NCT06835803
Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial
Is NCT06835803 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for glioblastoma (gbm).
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
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Disease stage
Grade: 4 (WHO)
WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: head and neck or cranial radiation
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.
Cannot have received: systemic or radiosensitizing therapy for a prior head and neck or central nervous system malignancy
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.
Cannot have received: investigational cancer drug for glioblastoma
any investigational cancer drug for glioblastoma prior to randomization
Cannot have received: non-surgical local or field treatment overlapping with the anticipated radiation field
Participants who have received or plan to receive any other form of non-surgical local or field treatment overlapping with the anticipated radiation field.
Lab requirements
Blood counts
Platelet count ≥ 100 x 10^9/L (100,000 cells/mm^3)
Kidney function
Serum creatinine ≤ 1.5 times the upper limit of normal
Liver function
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
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Brigham Cancer Center, Milford Hospital · Milford, Massachusetts
- Dana-Farber Brigham Cancer Center, South Shore Hospital · South Weymouth, Massachusetts
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