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Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors
Sponsor: Tata Memorial Centre
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
Proton Beam Therapy
Patients randomized to the experimental arm will be treated with proton beam therapy.
Photon Radiotherapy
Patients randomized to standard arm will be treated with photon therapy.
Locations (1)
Tata Memorial Centre
Mumbai, India