A specific physical feature used to measure or indicate the effects or progress of a disease based maximum utilisation of adjuvant therapy in glioblastoma

Phase 3

• Conditions: Health Condition 1: C719- Malignant neoplasm of brain, unspecified

• Registration Number: CTRI/2018/11/016349
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To improve overall <br/ ><br>survival in patients with methylation of the MGMT gene promoter by giving additional cycles of adjuvant <br/ ><br>chemotherapy (extended adjuvant TMZ) beyond the current standard 6-cycles of adjuvant TMZ <br/ ><br>chemotherapy (TMZ-6)Timepoint: 2-year overall survival,2- <br/ ><br>year progression-free survival, toxicity, and health-related quality of life.

Secondary Outcome Measures

Name	Time	Method
1.To identify optimal duration of extended adjuvant TMZ <br/ ><br>through a comparison of 12 cycles (TMZ-12) with 24 cycles (TMZ-24) of adjuvant TMZ. 2: To improve <br/ ><br>overall survival in patients with unmethylated MGMT using additional radiotherapy dose (dose-escalated RT) <br/ ><br>to metabolically active tumor identified though modern functional imaging (FET-PET/CT)Timepoint: 2-year overall survival,2- <br/ ><br>year progression-free survival, toxicity, and health-related quality of life.