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Shorter radiation before sarcoma surgery: could it reduce wound problems?

NCT ID NCT04946357

Disease control Sponsor: University Hospital Heidelberg 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether a shorter course (2-3 weeks) of proton or carbon ion radiation before surgery for extremity soft tissue sarcoma is safe and feasible. The main goal is to see if it reduces wound healing problems after surgery. The study enrolls 42 adults with resectable sarcoma and compares two types of particle radiation.

What this could mean

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

Active substance
proton or carbon ion radiation
What this could lead to
If successful, this could offer a shorter, more convenient radiation schedule before sarcoma surgery with fewer side effects and better wound healing.
What could go wrong
This is a small early-phase trial (42 participants) testing safety and feasibility, not yet proven to be better than standard treatment. The results may not apply to all sarcoma patients.

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 42 people

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

Started

Jun 2021

Expected to finish

Jul 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: * Histologically confirmed soft-tissue sarcoma of the extremities with an indication for perioperative radiation treatment * Resectable or marginally resectable * Karnofsky index of ≥ 70% * Age ≥ 18 years * Carried out patient education and written consent * Patient is capable to give informed consent Exclusion Criteria: * Stage IV (distant metastases) * Lymph node metastasis * Metal implants that influence treatment planning with ions * Previous radiotherapy in the treatment area * Desmoid tumors * Simultaneous participation in another clinical trial that could influence the results of the study. * Active medical implants for which no ion beam irradiation permit exists at the time of treatment (e.g., cardiac pacemaker, defibrillator)

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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

Contacts and locations

Locations

  • University Hospital Heidelberg, Department of RadioOncology

    Heidelberg, Baden-Wurttemberg, 69120, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.