NCT06831461 Proton Versus Photon Radiotherapy in Adults With Primary Brain Tumors
| NCT ID | NCT06831461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | Primary Brain Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 156 participants in total. It began in 2025-07-01 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06831461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Primary Brain Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06831461 currently recruiting?
Yes, NCT06831461 is actively recruiting participants. Contact the research team at archya1010@gmail.com for enrollment information.
Where is the NCT06831461 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT06831461 clinical trial?
NCT06831461 is sponsored by Tata Memorial Centre. The trial plans to enroll 156 participants.