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Could five doses of proton therapy before surgery improve sarcoma outcomes?

NCT ID NCT05917301

Disease control Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a shorter course of proton therapy (just five treatments) before surgery for soft tissue sarcoma is safe and effective. Researchers will track wound healing, side effects, and quality of life in 40 adult patients over two years. The goal is to see if this approach can speed up treatment while keeping outcomes good.

What this could mean

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

Active substance
proton therapy (hypofractionated)
What this could lead to
If successful, this could offer a faster, safer radiation option before sarcoma surgery, reducing treatment time and possibly improving recovery.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to all patients. There is a risk of wound complications or other side effects from the radiation.

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 40 people

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

Started

Apr 2024

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 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: * Adult patients (≥18 years of age) * Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma * WHO/ECOG status ≤2 Exclusion Criteria: * History of prior local radiation therapy * Inability to tolerate treatment position for duration of simulation or treatment * Tumor originating in retroperitoneal location * Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy * Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators. * Confirmed pregnancy.

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Conditions

The condition(s) this trial relates to.

sarcoma soft tissue sarcoma

As listed by the trial registrant

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

Soft tissue sarcoma

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

  • Sibley Memorial Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

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