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New trial aims to spare young brains from radiation damage

NCT ID NCT07338526

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a newer type of radiation called proton therapy (IMPT) can treat children's brain tumors just as well as standard X-ray therapy (IMRT) but with fewer long-term side effects. About 94 children aged 6 to 16 with low-grade brain tumors will be randomly assigned to receive either proton or X-ray radiation. Researchers will track their survival, thinking skills, hormone health, and hearing over five years to see which treatment is safer.

What this could mean

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

Active substance
Intensity-modulated proton therapy (IMPT)
What this could lead to
If successful, this could show that proton therapy reduces long-term brain damage, hormone problems, and hearing loss in children treated for brain tumors, potentially making it the new standard of care.
What could go wrong
This is a relatively small trial (94 children) and proton therapy is expensive and not widely available. The study is still recruiting, so results are years away, and it may not show a clear advantage over standard X-ray therapy.

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 94 people

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

Started

Aug 2025

Expected to finish

Jul 2035

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

6 to 16 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: * Age at irradiation: 6 to 16 years * Karnofsky/ Lansky Play Performance Status ≥ 60 * Diagnosis (histopathological/ radiological) of primary brain tumor with an expected survival of \>5 years (e.g., circumscribed gliomas, low grade gliomas, low-grade glial/ glioneuronal tumors, meningioma, pituitary tumors, schwannoma, craniopharyngioma, ependymoma) * 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.

benign neoplasm of brain brain cancer low grade glioma

As listed by the trial registrant

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

Brain tumor benign Brain tumor, pediatric

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 Hospital

    RECRUITING

    Mumbai, Maharashtra, 400012, India

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