RANDOMIZED CONTOLLED TRIAL COMPARING HYPOFRACTIONATED RADIATION THERAPY VERSUS CONVENTIONAL RADIATION THERAPY IN GLIOBLASTOMA

A RANDOMIZED PHASE 2 STUDY OF HYPOFRACTIONATED RADIATION THERAPY WITH SIMULTANEOUS INTEGRATED BOOST (SIB) VERSUS CONVENTIONAL RADIATION THERAPY IN GLIOBLASTOMA - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092759

Enrollment

Registered

2025-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

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

Interventions

Intervention1: Adjuvant Radiation therapy: Experimental Arm- hypofractionated dose of 63Gy/ 52.5Gy in 15 fractions over 3 weeks by simultaneous integrated boost Control Intervention1: Adjuvant Radiati

Eligibility

Inclusion criteria

Inclusion criteria: 1. ECOG PS of 0 to 2, or Karnofsky PS of 60 or more 2. Post surgery (resection or biopsy or tumour decompression) 3. Histopathologically confirmed glioblastoma, CNS WHO Group 4 4. Normal organ function 5. Negative serum pregnancy test 6. Written consent given

Exclusion criteria

Exclusion criteria: 1. Tumours close to the brainstem or spinal cord 2. ECOG PS of 3 or 4, or Karnofsky PS of less than 60 3. Previous history of malignancy, coagulopathy or CVA 4. Previous diagnosis of psychiatric or neurological comobridities 5. Previous history of radiation exposure to brain 6. Contraindications for MR imaging or contrast injection 7. No histopathological diagnosis of glioblastoma 8. Deranged organ function 9. Patients with raised intracranial tension 10. Written consent not given

Design outcomes

Primary

Measure	Time frame
To assess and compare toxicity profile of patients receiving conventional radiation therapy versus hypofractionated radiation therapy To assess and compare quality of life of patients treated with conventional radiation therapy versus hypofractionated radiation therapyTimepoint: Patients will be assessed at 3 months, 6 months, 9 months and 12 months post completion of radiation therapy.	—

Secondary

Measure	Time frame
To assess and compare the median overall survival (OS) of patients receiving conventional and moderately hypofractionated regimes of adjuvant radiotherapy To assess and compare the median progression free survival (PFS) of patients receiving conventional and moderately hypofractionated regimes of adjuvant radiotherapy To assess and compare the impact on cognition in patients receiving conventional and moderately hypofractionated regime using Montreal Cognitive Assessment (MoCA) To assess and compare the caregiver burden for patients receiving conventional and moderately hypofractionated regime using Zarit Caregiver Burden Scale Dosimetric comparison between the conventional and moderately hypofractionated regimes for the adjuvant treatment of GBMTimepoint: Patients will be assessed at 3 months, 6 months, 9 months and 12 months post completion of radiation therapy.	—

Measure

Time frame

To assess and compare the median overall survival (OS) of patients receiving conventional and moderately hypofractionated regimes of adjuvant radiotherapy To assess and compare the median progression free survival (PFS) of patients receiving conventional and moderately hypofractionated regimes of adjuvant radiotherapy To assess and compare the impact on cognition in patients receiving conventional and moderately hypofractionated regime using Montreal Cognitive Assessment (MoCA) To assess and compare the caregiver burden for patients receiving conventional and moderately hypofractionated regime using Zarit Caregiver Burden Scale Dosimetric comparison between the conventional and moderately hypofractionated regimes for the adjuvant treatment of GBMTimepoint: Patients will be assessed at 3 months, 6 months, 9 months and 12 months post completion of radiation therapy.

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Countries

India

Contacts

Public ContactDr Subhash Gupta

All India Institute of Medical Sciences, New Delhi

drsubhashgupta72@gmail.com9868398341

Outcome results

None listed

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