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A study comparing Hypofractionated Radiotherapy (HART) with Conventional Fractionated Radiotherapy (CFRT) in Newly Diagnosed High Grade Glioma (HGG)

A Pilot study comparing Hypofractionated Accelerated Radiotherapy (HART) Vs Conventional Fractionated Radiotherapy (CFRT) in Newly Diagnosed High Grade Glioma (HGG): A Randomised non-inferiority Trial - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064914
Enrollment
60
Registered
2024-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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: Radiotherapy: In Arm A (CONVENTIONAL FRACTIONATED RADIOTHERAPY, CFRT) total dose of 60 Gy in 30 fractions at 2 Gy per fraction in 2 phases- In phase 1 : Total dose of 46 Gy in 23 fract

Sponsors

Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed cases of high grade gliomas: Anaplastic Astrocytoma (Grade 3), Astrocytoma (grade 4), Glioblastoma (Grade 4) 2. Age = 18 years 3. KPS = 70 4. Adequate renal, hepatic and hematologic function 5. Patients willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Previous history of chemoradiation 3. Other primary, recurrent or metastatic disease 4. Patients with significant life-threatening co-morbidities 5. History of acute or chronic liver disease

Design outcomes

Primary

MeasureTime frame
1. Response rate as per RANO criteria at 3, 6, 9 months of treatment. 2. Progression Free survival (PFS) at 9 months 3. Overall Survival (O.S.) between the 2 arms at 9 months 4. Comparison of quality of life between two arms 5. Recurrence patterns of the two arms Timepoint: At 3,6,9 months

Secondary

MeasureTime frame
Recurrence pattern in 2 armTimepoint: At 3,6,9 months

Countries

India

Contacts

Public ContactDr Dharmendra Kumar Sah

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH

drnarendra74@gmail.com7087009393

Outcome results

None listed

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