Could fewer radiation sessions mean fewer complications for sarcoma patients?
NCT ID NCT03819985
First seen Jun 24, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This phase 2 trial is testing a shorter, higher-dose radiation schedule given before surgery for soft tissue sarcoma of the arms, legs, or trunk. The goal is to see if this approach reduces wound complications after surgery while still controlling the cancer. About 122 patients are taking part, and researchers are comparing results to historical data.
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 offer a more convenient and safer pre-surgery radiation option for soft tissue sarcoma patients, with fewer wound complications.
- What could go wrong
- This is a mid-stage trial with only 122 participants, so results may not apply to all patients. The shorter radiation course might still cause wound problems or not control the cancer as well as standard treatment.
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
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122 people
The number who actually took part.
- Started
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Dec 2018
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Tumor located in the soft tissues of the extremities or superficial trunk * Deemed a candidate for complete macroscopic resection of the primary sarcoma * Histologically confirmed sarcoma arising in soft tissue * Patient may have had excisional biopsy of all gross disease at an outside facility with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon in the participating institution recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of neoadjuvant irradiation (a sandwich approach of marginal excision--\>radiation therapy(RT)--\> wide excision, as per our standard practice) * No evidence of nodal or distant metastases as determined by clinical examination or any form of imaging * Has provided written informed consent for participation in this trial * Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less * Life expectancy greater than 6 months * Patients capable of childbearing are using adequate contraception * Available for follow-up 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 * Women who are pregnant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could 5 days of radiation replace 25 for sarcoma patients?
- Experimental combo aims to boost immune attack on sarcoma before surgery
- New drug combo aims to stall rare Cancer's spread
- Can fewer, stronger radiation doses before sarcoma surgery reduce wound problems?
- New hope for rare sarcomas: chemo plus immunotherapy combo enters phase III trial