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Could Pre-Surgery proton beams boost brain tumor outcomes?

NCT ID NCT07710040

Disease control Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial investigates whether giving a short course of targeted proton radiation before surgery is safe for people with high-grade gliomas, an aggressive type of brain tumor. Nine participants will receive one of three escalating doses of proton therapy, followed by standard surgery and chemoradiotherapy. The goal is to find the highest safe dose and see if this approach improves tumor removal and survival.

What this could mean

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

Active substance
preoperative proton stereotactic radiotherapy
What this could lead to
If successful, this approach could improve tumor control and survival for patients with high-grade gliomas by combining targeted radiation before surgery with standard treatment.
What could go wrong
This is a very early phase 1 trial with only 9 participants, so the safety and effectiveness are not yet established. There is a risk of radiation-induced toxicity, and the study may be stopped if unacceptable side effects occur.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 9 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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 years and older

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: * radiologically confirmed (MRI and/or PET with amino-acids) diagnosis of high-grade glioma * single foci * ECOG 0-2 status * tumor location and volume, eligible for gross total resection (GTR) * signed informed consent Exclusion Criteria: * multifocal disease * ECOG 3-4 * inability to achieve GTR

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Conditions

The condition(s) this trial relates to.

malignant glioma

As listed by the trial registrant

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

High grade gliomas

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

  • Proton Therapy Department, A. Tsyb Medical Radiological Research Center - branch of the National Medical Radiological Research Center

    RECRUITING

    Obninsk, Kaluga Oblast, 249036, Russia

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