Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06831461

Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors

Led by Tata Memorial Centre · Updated on 2025-09-16

156

Participants Needed

1

Research Sites

391 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study will be done in adults with brain tumors having good prognosis requiring treatment with radiotherapy. The current practice for brain radiotherapy involves treatment using X rays (photon radiotherapy). Proton beam therapy is a more advanced form of delivering radiation, which allows the reduction of the dose of radiation to the parts of the brain surrounding the tumor. After treatment with photon radiotherapy, certain late effects of radiation, like memory decline, hormonal deficits, hearing loss, and worsening of neurological function, can occur in some patients. From the evaluation of dose profiling, proton beam therapy has the potential to reduce the possibility of side effects by reducing the dose to critical organs. However, there is no clinical data to demonstrate whether the 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.

CONDITIONS

Official Title

Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary brain tumors
  • Age at irradiation: 18 to 70 years
  • Karnofsky Performance Status 60
  • Diagnosis (histopathological or radiological) of primary brain tumor with expected survival over 5 years (e.g., grade 2-3 diffuse glioma, low-grade glial/glioneuronal tumors, ependymoma, meningioma, pituitary tumors, schwannoma, craniopharyngioma)
  • Planned for focal cranial radiotherapy
  • Informed consent given
Not Eligible

You will not qualify if you...

  • Previous brain re-irradiation
  • Planned palliative radiotherapy
  • Multifocal or multicentric brain disease
  • Planned whole brain or craniospinal irradiation
  • Planned hypo-fractionated or stereotactic radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tata Memorial Centre

Mumbai, India

Actively Recruiting

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Research Team

A

Archya Dasgupta, MBBS MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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