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New trial tests if proton beam therapy spares brain function better than standard X-Rays

NCT ID NCT06831461

Disease control Sponsor: Tata Memorial Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial compares proton beam therapy to standard photon radiotherapy in 156 adults with primary brain tumors. The goal is to see if proton therapy, which delivers less radiation to healthy brain tissue, improves functional survival—meaning living longer without tumor recurrence, death, or serious side effects like memory decline, hearing loss, or hormone problems. Participants are randomly assigned to one of the two radiation types and followed for at least 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Proton beam therapy
What this could lead to
If proton therapy proves better, it could become the new standard for brain tumor radiotherapy, reducing memory loss, hearing loss, and hormone problems while maintaining survival.
What could go wrong
This is a phase 3 trial, but the benefit is not yet proven. Proton therapy is more expensive and less available, and the study may show no meaningful difference in side effects or survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

brain cancer craniopharyngioma diffuse astrocytoma ependymoma glioma low grade glioma meningioma pituitary gland adenoma Pituitary Neoplasms pituitary tumor primary brain neoplasm schwannoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse glioma Low grade CNS tumors Meningioma Pituitary adenoma Primary brain tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tata Memorial Centre

    RECRUITING

    Mumbai, India

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