This is a trial for the glioblastoma patients after surgery. It compares the short course of radiotherapy with short course radiotherapy and temozolomide after surgery. Comparison between two arms will be done in terms of overall survival, progression free survival and quality of life.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Histopathologically confirmed newly diagnosed Glioblastoma, WHO grade IVHealth Condition 2: C719- Malignant neoplasm of brain, unspecifiedHealth Condition 3: C719- Malignant neoplasm of brain, unspecifiedHealth Condition 4: G89-G99- Other disorders of the nervous system
- Registration Number
- CTRI/2018/07/014931
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
1. Histopathologically confirmed newly diagnosed Glioblastoma(GBM), WHO grade IV.
2. Age and KPS (Appendix I) criteria:
i)>=65 years old and KPS score of 50-100.
ii)50 to 65 years old and KPS score of 50-70.
Exclusion Criteria
Patients who have received prior chemotherapy or radiotherapy.
Patients not willing to complete the quality of life questionnaires.
Other co-morbidities like diabetes, hypertension, etc. not controlled with medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Overall Survival <br/ ><br>2. Progression free survivalTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method quality of life assessmentTimepoint: 1 month post radiotherapy,3 months post radiotherapy and 6 months post radiotherapy