Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: Methylated stratum
Unmethylated stratum: Methylated stratum: TMZ 12 cycles/ TMZ 24 cycles
Unmethylated stratum: Dose escalated RT/TMZ
Control Intervention1: Methylated Stratum
Unmethyla
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly-diagnosed GBM or variants (WHO grade IV) proven on histopathology of tumor tissues resected at decompressive surgery/biopsy 2. Adults >=18 years of age at time of enrolment 3. Availability of tumor tissues for assessing MGMT methylation status 4. KarnofskyPerformance Status (KPS) >=70 and Neurologic Performance Status (NPS) 0-1 5. Adequate bone marrow reserve (absolute neutrophil count >1500 and platelet count >1,00,000) 6. Normal liver and renal function tests 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Recurrent/progressive GBM 2. Transformed secondary GBM from a previous lowergrade glioma 3. Diffuse gliomatosis necessitating whole brain irradiation 4. Prior history of any other malignancy 5. Concurrent treatment with any other investigational agent 6. Any inter-current illness that precludes safe administration of TMZ 7. Unwillingness to comply with proposed therapy and/or follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To improve overall survival in patients with methylation of the MGMT gene promoter by giving additional cycles of adjuvant chemotherapy (extended adjuvant TMZ) beyond the current standard 6-cycles of adjuvant TMZ chemotherapy (TMZ-6)Timepoint: 2-year overall survival,2- year progression-free survival, toxicity, and health-related quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To identify optimal duration of extended adjuvant TMZ through a comparison of 12 cycles (TMZ-12) with 24 cycles (TMZ-24) of adjuvant TMZ. 2: To improve overall survival in patients with unmethylated MGMT using additional radiotherapy dose (dose-escalated RT) to metabolically active tumor identified though modern functional imaging (FET-PET/CT)Timepoint: 2-year overall survival,2- year progression-free survival, toxicity, and health-related quality of life. | — |
Countries
India
Contacts
Public ContactDr Tejpal Gupta
Tata Memorial Hospital
Outcome results
None listed