CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 156 target
Drug / intervention
Proton Beam Therapy +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 7
  • Primary brain tumors
  • Age 18 to 70 years at irradiation
  • Histopathologically or radiologically confirmed diagnosis
  • Expected survival greater than 5 years
Key exclusion· 5
  • Re-irradiation
  • Palliative radiotherapy
  • Multifocal or multicentric disease
  • Planned for whole brain irradiation or craniospinal irradiation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06831461
NCT06831461N/ARecruitingOn TrackUpdated 9mo ago

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

Tata Memorial Centre·interventional·Posted Feb 18, 2025·Updated Sep 16, 2025

In Brief

A clinical study evaluating Proton Beam Therapy and Photon Radiotherapy for Primary Brain Tumors and 4 related conditions. Currently recruiting, targeting 156 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ARecruiting
202520262027202820292030203120322033
First PostedFeb 18, 2025
Enrollment StartJul 1, 2025
Primary CompletionDec 31, 2032
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 1.4 years agoPrimary completion in 6.5 years

Interventions

Proton Beam Therapyradiation

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

Photon Radiotherapyradiation

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