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Study identifier: NCT04765514 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients

Condition: Glioblastoma Multiforme  ·  Sponsor: AHS Cancer Control Alberta

PhasePhase 2
Planned participants107
Who can joinAll sexes, 65 Years to no upper limit
Healthy volunteersNo

About this study

Currently, the optimal treatment regimen for elderly Glioblastoma (GBM) patients with poor performance status (PS) is unknown. Based on data for elderly GBM patients and the limited data for patients with poor PS, hypofractionated RT or a short course of Temozolomide (TMZ) may provide survival benefit without the added toxicity and inconvenience of a more protracted treatment regimen. In particular, treatment with RT or TMZ monotherapy on the basis of methylated O6 - methyl guanine - DNA methyltransferase (MGMT) promoter methylation status, followed by the alternative therapy at progression, may provide a safe and effective treatment regimen for patients with poor PS. The hypothesis of this trial is that in elderly GBM patients with poor performance status (age ≥ 65 years and KPS 60-70), a chemotherapy alone (TMZ monotherapy) approach to therapy results in non-inferior overall survival compared to combined TMZ/RT. It is hypothesized that chemotherapy will result in non-inferior progression-free survival, reduced toxicity and increased cost-effectiveness compared to combined chemoradiotherapy. Primary objective: • To compare overall survival of standard therapy vs chemotherapy in elderly and frail patients with newly diagnosed GBM. Secondary objective: * To evaluate progression-free survival following treatment in both arms. * To evaluate adverse events according to CTCAE criteria in both arms. * To evaluate health-related quality-of-life as assessed by MoCA and EORTC Q…

This description comes directly from the study's public registry record.

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Locations (2)

Arthur J.E. Child Comprehensive Cancer Center (formerly Tom Baker Cancer Centre)Calgary, Alberta, CanadaTerminated
Cross Cancer InstituteEdmonton, Alberta, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT04765514