Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
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
| Condition(s) | Glioblastoma Multiforme |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: 1. Newly-diagnosed, histologically proven, intracranial glioblastoma with maximal safe resection. Biopsy alone is expected if resection is not possible. MGMT promoter methylation status must be tested and the results positive (defined as all non-negative MGMT status, including intermediate or indeterminate status (i.e., with cutoff higher than the MGMT negative threshold). 2. History and physical examination, including neurological examination, within 14 days prior to randomization. 3. Age ≥ 65 \& KPS of 60 - 70 4. Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization. 5. Laboratory evaluation within 7 days prior to randomization, with adequate function as defined below: 1. ANC ≥ 1.5 x 109/L 2. Platelets ≥ 100 x 109/L 3. Serum creatini |
| Ages | 65 Years |
| Sex | All |
| Lead sponsor | AHS Cancer Control Alberta |
| Locations | Calgary, Alberta, Canada; Edmonton, Alberta, Canada |
| Start date | 2022-07-27 |
| NCT ID | NCT04765514 |
| Official listing | https://clinicaltrials.gov/study/NCT04765514 |