Health Condition 1: D496- Neoplasm of unspecified behavior of brain
Conditions
Interventions
Intervention1: Radiotherapy: The test arms will comprise of dose escalated hypo-fractionated RT (5 fractions/10 fractions). The usage of TMZ will be standard across both arms.
Control Intervention1: R
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Patients with biopsy proven IDH wild type GBM or imaging defined GBM Neurological Predictor Scale (NPS) 2-3 Unfit for surgery and referred for direct RT Age greater tuan equal to 50 years
Exclusion criteria
Exclusion criteria: IDH mutant glioma Histone altered glioma Multifocal disease or Gliomatosis like appearance which necessitates whole brain RT Disseminated disease in brain or spine NPS = 0-1 or = 4 Karnofsky Performance Status score less than 50(Patient requires considerable assistance and frequent medical care) Prior administration of any systemic therapy directed against glioma (eg.Temozolomide, CCNU, Bevacizumab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is overall survival at 1 year, which will be defined as the time from randomization to death from any cause will be considered as an event.Timepoint: The primary endpoint of the study is overall survival at 1 year, which will be defined as the time from randomization to death from any cause will be considered as an event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival(PFS) at 1 year-Progression Free Survival will be defined as the time elapsed fromthe date of randomization to the date of clinico-radiological progression or death.Timepoint: 1 year;Toxicity assessment with the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)Timepoint: At baseline, at RT conclusion;Quality of life indices using the EORTC QLQC- 30 and its BN -20 moduleTimepoint: At baseline. at RT conlusion and there after at 6 monthly follow up;Quality of life without symptoms or toxicity in three health states TOX (toxicity), TWIST (time without symptoms) and REL (relapse)Timepoint: At baseline. at RT conlusion and there after at 6 monthly follow up | — |
Countries
India
Contacts
Public ContactDr Abhishek Chatterjee
Tata Memorial Centre
Outcome results
None listed