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Proton vs. photon: which radiation works better for leptomeningeal metastases?

NCT ID NCT04343573

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two radiation approaches for leptomeningeal metastases, a condition where cancer spreads to the fluid and lining around the brain and spinal cord. One group receives proton craniospinal irradiation, which targets the entire brain and spine, while the other gets standard photon radiation that only treats areas causing symptoms. The goal is to see which better prevents the cancer from worsening and improves symptoms. The trial enrolled 102 patients with solid tumors.

What this could mean

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

Active substance
Radiation therapy (proton craniospinal irradiation or involved-field photon radiation)
What this could lead to
If proton CSI works better, it could offer a more effective way to control leptomeningeal metastases and improve symptoms for people with advanced solid tumors.
What could go wrong
This is a phase 2 trial with only 102 participants, so results are not definitive. Proton CSI may not be more effective than standard photon therapy and could have different side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Apr 2020

Finished

Feb 2026

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

Up to 99 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: * Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology * Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases * Patients of all ages * KPS ≥ 60 for participants ≥ 16 years old, and Lansky ≥ 60 for participants \< 16 years old * For adult patient, the patient/ legally authorized representative is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent. * Adequate bone marrow function: * Hemoglobin \> 8g/dL * Absolute neutrophil count \>1,000/mm * Platelet count \> 100,000/mm * Female subjects must either be of non-reproductive potential (i.e. pediatric patients, OR postmenopausal by history \[≥ 60 years old, or with no menses for \>1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment. * Patient at reproductive potential must agree to practice an effective contraceptive method. Exclusion Criteria: * Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy * Patient with extensive systemic disease and without reasonable systemic treatment options * Patient who is unable to undergo MRI brain and spine with gadolinium contrast * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances * Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

Meningeal Carcinomatosis neoplastic meningitis

As listed by the trial registrant

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

Leptomeningeal metastases

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Limitedl protocol activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

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