Proton versus photon radiation for adults with primary brain tumors
Proton Versus Photon Radiotherapy In Adults With Primary Brain Tumors Evaluating Functional Survival: A Phase 3 Randomized Controlled Trial (PRIDE)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | radiation, Chemotherapy |
| Locations | 1 site (Mumbai) |
| Trial ID | NCT06831461 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mumbai
- Tata Memorial Centre — Mumbai, India (Recruiting)
Study contacts
- Study coordinator: Archya Dasgupta, MBBS MD
- Email: archya1010@gmail.com
- Phone: 8097081506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.