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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.

A randomized phase III study of short course (one week) radiation therapy with or without temozolomide in elderly and/or frail patients with newly diagnosed glioblastoma (GBM) - GBM Glioblastoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014931
Enrollment
70
Registered
2018-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Histopathologically confirmed newly diagnosed Glioblastoma, WHO grade IV Health Condition 2: C719- Malignant neoplasm of brain, unspecified Health Condition 3: C719- Malignant neoplasm of brain, unspecified Health Condition 4: G89-G99- Other disorders of the nervous system

Interventions

Intervention1: Hypofractionated radiotherapy with concurrent temozolomide followed by adjuvant radiotherapy: second arm will receive hypofractionated radiotherapy with 25 Gray in 5 fractions with conc

Sponsors

Post Graduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Overall Survival 2. Progression free survivalTimepoint: 6 months

Secondary

MeasureTime frame
quality of life assessmentTimepoint: 1 month post radiotherapy,3 months post radiotherapy and 6 months post radiotherapy

Countries

India

Contacts

Public ContactDr Subhash Thakur

Postgraduate Institute of Medical Education & Research

drnarendra74@gmail.com9814968775

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026