NCT04562480Active, not recruitingPhase 2
Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk
A Phase II Study of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
This phase II trial investigates the effects of hypofractionated radiation therapy before surgery on wound complications associated with surgery in treating patients with soft tissue sarcoma of the extremity (arms, hands, legs or feet) and superficial trunk that has not spread to other parts of the body (localized) and can be removed by surgery (resectable). Hypofractionated is a shorter radiation therapy treatment length (fewer radiation treatment days) and administers the total radiation dose as larger daily doses, compared to conventionally fractionated therapy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 18 Sept 2020
- Start date
- 30 Nov 2020
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Mayo Clinic
- Diseases
- Sarcoma
- NCT number
- NCT04562480
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 120
- From 30 Nov 2020 to the primary completion date, 31 Oct 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.