Clinical trial · Interventional
Proton Versus Photon Radiotherapy in 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Glioma | Diffuse Glioma | ONTOLOGY_EXACT | 0.98 |
| Low Grade CNS Tumors | — | UNRESOLVED | — |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Primary Brain Tumors | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photon Radiotherapy | Radiation | — | UNRESOLVED |
| Proton Beam Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Photon therapy (standard arm)
- description
- 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.
- interventionNames
- Radiation: Photon Radiotherapy
- type
- EXPERIMENTAL
- label
- Proton beam therapy (experimental arm)
- description
- The patients in the experimental arm will undergo focal radiotherapy to an equivalent dose using proton beam therapy.
- interventionNames
- Radiation: Proton Beam Therapy
Primary outcomes (1)
- measure
- 5-year functional survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDasgupta A, Ghosh S, Chatterjee A, Kannan S, Goswami S, Ranjith CP, Punde R, Meena L, Shinde P, Konthoujam M, Phurailatpam R, Sutar A, Patil D, Sahu A, Sridhar E, Moiyadi A, Menon N, Puranik A, Bano N, Gupta T. Proton versus photon radiotherapy in adults with primary brain tumors evaluating functional survival: a phase 3 randomized controlled trial study protocol (PRIDE). Radiat Oncol. 2026 Feb 14;21(1):38. doi: 10.1186/s13014-025-02785-7. PMID 41689093