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New proton therapy spares spine growth in kids with brain cancer

NCT ID NCT07589361

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a new way to give radiation to children with brain tumors that need whole-brain and whole-spine treatment. The technique, called vertebral body-sparing proton therapy, aims to protect the front of the spine bones to preserve bone marrow and growth. Researchers will check how safe this approach is and how well it controls the tumor over 5 years. About 38 children and teens aged 3 to 18 will take part.

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.

Participants

About 38 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2033

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.

Who is studied

This is a prospective observational study enrolling 38 pediatric patients aged \>3 years and ≤18 years with histologically confirmed central nervous system tumors requiring craniospinal irradiation (CSI). Patients will be assigned to 2 cohorts: low-dose CSI and high-dose CSI. All participants will receive vertebral body-sparing intensity-modulated proton therapy (IMPT) and standard chemotherapy according to clinical guidelines.

Ages

4 to 18 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: * The patient's legal guardian voluntarily signs the written informed consent form. * Age at diagnosis \> 3 years and ≤ 18 years. * Histopathologically confirmed diagnosis of a central nervous system (CNS) tumor. * Indication for craniospinal irradiation (CSI) confirmed by multidisciplinary team (MDT) discussion. * Karnofsky Performance Score (KPS) ≥ 80. * For postoperative patients, complete healing of the surgical incision with no evidence of wound infection or other complications. * For women of childbearing potential, effective contraception must be used for at least one month prior to screening, and they must commit to continued contraception throughout the study period and for the required time after study completion. Exclusion Criteria: * Previous receipt of any form of spinal radiotherapy. * Previous major spinal surgery for any reason. * Presence of clinically significant and confirmed spinal deformity at enrollment (e.g., Cobb angle \> 10° measured by MRI or X-ray). * Presence of medical contraindications to proton radiotherapy. * Presence of any severe, uncontrolled systemic disease (e.g., active infection, severe cardiac, hepatic, renal, or respiratory insufficiency) that, in the investigator's judgment, makes the subject unsuitable for treatment under this protocol. * Female patients who are pregnant or breastfeeding. * Presence of any severe cognitive or psychiatric disorder that prevents understanding of or cooperation with study assessments.

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Conditions

The condition(s) this trial relates to.

atypical teratoid rhabdoid tumor ependymoma germinoma medulloblastoma rhabdoid tumor

As listed by the trial registrant

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

Atypical teratoid/rhabdoid tumor (at/RT) Ependymoma Germinoma Medulloblastoma Pediatric central nervous system tumors

How to take part

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  1. The official record

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

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