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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Primary brain tumors

• Age at irradiation: 18 to 70 years

• Karnofsky Performance Status ≥ 60

• Diagnosis (histopathological/ radiological) of primary brain tumor with an expected survival of \>5 years (e.g., grade 2-3 diffuse glioma, low-grade glial/ glioneuronal tumors, ependymoma, meningioma, pituitary tumors, schwannoma, craniopharyngioma, etc.)

• Planned for focal cranial radiotherapy

• Informed consent taken

Locations
Other Locations
India
Tata Memorial Centre
RECRUITING
Mumbai
Contact Information
Primary
Archya Dasgupta, MBBS MD
archya1010@gmail.com
8097081506
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 156
Treatments
Other: Photon therapy (standard arm)
Patients in the standard arm will undergo focal cranial radiotherapy using photons (X-rays) with image guidance using IMRT, VMAT, or helical intensity-modulated techniques.
Experimental: Proton beam therapy (experimental arm)
The patients in the experimental arm will undergo focal radiotherapy to an equivalent dose using proton beam therapy.
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov