Proton versus photon radiation for adults with primary brain tumors
Official title: Proton Versus Photon Radiotherapy In Adults With Primary Brain Tumors Evaluating Functional Survival: A Phase 3 Randomized Controlled Trial (PRIDE)
Run by Tata Memorial Centre · NCT06831461 · Data updated 2026-11-12
This trial will test whether proton beam radiation causes fewer long-term side effects than standard photon (X-ray) radiation in adults aged 18–70 with primary brain tumors who are expected to live more than five years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 156 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | radiation, Chemotherapy |
| Locations | 1 site (Mumbai) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | December 31, 2032 |
| Study ends | December 31, 2032 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT06831461 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults 18–70 with primary brain tumors (e.g., low‑grade gliomas, IDH‑mutant grade 2/3 gliomas, ependymoma, meningioma, pituitary tumor, schwannoma) who have Karnofsky ≥60, are planned for focal cranial radiotherapy, and have an expected survival of more than five years.
✕Probably not a fit
Patients requiring whole‑brain or craniospinal irradiation, palliative treatment, re‑irradiation, multifocal or multicentric disease, or those planned for stereotactic/hypofractionated regimens are excluded and unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial will enroll 156 adults (18–70 years) with primary brain tumors and expected survival over five years and randomize them 1:1 to focal proton beam therapy or standard photon radiotherapy delivered with image-guided IMRT/VMAT/helical techniques. The proton arm uses modern proton delivery to reduce dose to normal brain and organs at risk, while the photon arm uses contemporary X‑ray planning and delivery per institutional standards. Outcomes include late effects such as neurocognitive decline, hormonal deficits, hearing loss, neurological function, and survival assessed over long-term follow-up. Randomization uses permuted blocks with stratification and treatments follow standard indications based on histology, grade, and extent of disease.
Why it matters
Potential benefit: If successful, proton therapy could lower radiation-related cognitive, hormonal, and sensory side effects for long‑surviving adults with brain tumors while maintaining tumor control.
How similar studies have gone: Dosimetric and pediatric studies suggest proton therapy reduces dose to normal brain and may lower late toxicities, but randomized clinical evidence in adults comparing clinical outcomes is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Re-irradiation * Palliative radiotherapy * Multifocal or multicentric disease * Planned for whole brain irradiation or craniospinal irradiation * Planned for hypo-fractionated or stereotactic radiotherapy
Where it's running
-
Tata Memorial Centre
Mumbai, India Recruiting
Study contacts
- Study coordinator: Archya Dasgupta, MBBS MD
- Email: archya1010@gmail.com
- Phone: 8097081506
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.