Can fewer, stronger radiation doses before sarcoma surgery reduce wound problems?

NCT ID NCT04562480

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests a shorter course of radiation (hypofractionated) given before surgery for soft tissue sarcoma of the arms, legs, or trunk. The goal is to see if this approach reduces major wound complications after surgery. About 120 adults with localized, resectable sarcoma are enrolled. The study compares the wound complication rate to standard radiation schedules.

What this could mean

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

Active substance: Hypofractionated radiation therapy
What this could lead to: If successful, this could lead to a shorter, more convenient radiation schedule before sarcoma surgery with fewer wound healing problems.
What could go wrong: This is a mid-stage trial with 120 participants, so results may not apply to everyone. The higher daily radiation dose could increase side effects like wound complications or tissue damage.

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

120 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Oct 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: * Newly diagnosed, histological confirmation of soft tissue sarcoma of the extremities (including limb girdle) or superficial trunk that present as either - * Deemed a candidate for complete macroscopic resection of the primary sarcoma OR * Having had non-oncologic excisional procedure with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of preoperative radiation therapy * No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging * Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 3 * Life expectancy greater than 6 months * Patients capable of childbearing must use adequate contraception * Ability to complete questionnaire(s) by themselves or with assistance * Ability to provide written informed consent * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) Exclusion Criteria: * Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma. In other words, treatment on this trial would require re-irradiation of tissues * Patients with nodal or distant metastases * Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception

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Conditions

The condition(s) this trial relates to.

soft tissue sarcoma

As listed by the trial registrant

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

Resectable soft tissue sarcoma Stage I soft tissue sarcoma of the trunk and extremities ajcc V8 Stage IA soft tissue sarcoma of the trunk and extremities ajcc V8 Stage IB soft tissue sarcoma of the trunk and extremities ajcc V8 Stage II soft tissue sarcoma of the trunk and extremities ajcc V8

Can fewer, stronger radiation doses before sarcoma surgery reduce wound problems?

What the study statuses mean