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RECRUITING
NCT06831461
NA

Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors

Sponsor: Tata Memorial Centre

View on ClinicalTrials.gov

Summary

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.

Official title: Proton Versus Photon Radiotherapy In Adults With Primary Brain Tumors Evaluating Functional Survival: A Phase 3 Randomized Controlled Trial (PRIDE)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2025-07-01

Completion Date

2032-12-31

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

RADIATION

Proton Beam Therapy

Patients randomized to the experimental arm will be treated with proton beam therapy.

RADIATION

Photon Radiotherapy

Patients randomized to standard arm will be treated with photon therapy.

Locations (1)

Tata Memorial Centre

Mumbai, India