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Clinical Trials/CTRI/2025/03/082568
CTRI/2025/03/082568RecruitingPhase 3

Proton versus Photon Radiotherapy In Adults with primary brain tumors Evaluating functional survival A Phase 3 Randomized Controlled Trial

Tata Memorial Hospital1 site in 1 country156 target enrollmentStarted: April 1, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
156
Locations
1
Primary Endpoint
Primary endpoint

Study Overview

Brief Summary

This study will be done in adults with brain tumors having good life expectancy requiring treatment with radiotherapy. The current practice for brain radiotherapy involves an advanced technique of radiation using X rays (photon radiotherapy). Another newer technology for delivering radiation is available called proton beam therapy, which allows to reduce the lower dose of radiation to the parts pf brain surrounding the tumor. After treatment with photon radiotherapy certain late effects of radiation like memory decline, hormonal deficits, hearing loss, worsening of neurological function can occur in some patients. From evaluation of dose profiling, proton beam therapy has potential to reduce the possibility of side effects by reducing dose to critical organs. However, there is no clinical data to demonstrate whetherthe theoretical dose reduction translates to a clinically meaningful benefit. In the proposed study, 156 patients will be randomly allocated to either proton or photon radiotherapy in 1: 1 ratio. The primary objective of the study is to explore whether proton therapy improves functional survival which is life expectancy without recurrence, death or complications from radiotherapy.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Primary brain tumors
  • Age at irradiation 18 to 70 years
  • Karnofsky Performance Status more than 60
  • Diagnosis histopathological radiological of primary brain tumor with an expected survival of above 5 years
  • Planned for focal cranial radiotherapy
  • Informed consent taken.

Exclusion Criteria

  • Reirradiation
  • Palliative radiotherapy
  • Multifocal or multicentric disease
  • Planned for whole brain irradiation or craniospinal irradiation
  • Planned for hypofractionated or stereotactic radiotherapy.

Outcomes

Primary Outcomes

Primary endpoint

Time Frame: 5 years

The 5 year rate of overall survival without functional deterioration functional survival equal to fS will be

Time Frame: 5 years

calculated from the date of randomization. An event concerning the primary endpoint will include

Time Frame: 5 years

Neurocognitive decline

Time Frame: 5 years

CTCAE grade 2 ototoxicity

Time Frame: 5 years

New neuroendocrine axis dysfunction or worsening of pre existing dysfunction

Time Frame: 5 years

Neurological and functional impairment

Time Frame: 5 years

CTCAE gr 3 radionecrosis

Time Frame: 5 years

Disease progression

Time Frame: 5 years

All cause mortality

Time Frame: 5 years

Secondary Outcomes

  • Secondary endpoints:(1. Overall survival & Progression-free survival.)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr ARCHYA DASGUPTA

Tata Memorial Hospital

Study Sites (1)

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