Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk

NCT04562480 | Active Not Recruiting Phase 2 Results DMC FDA Device

• 3 other identifiers: MC1973NCI-2020-0681119-011871
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Major Wound Complications

  Will be assessed by the number of patients who experience major wound complications within 120 days following surgery. Major wound complication is defined as secondary unplanned operation under general or regional anesthesia for wound repair (e.g., debridement, operative drainage, or secondary wound closure including rotationplasty, free flaps or skin grafts); or wound management without secondary operation including invasive procedures (e.g., aspiration of seroma or readmission for wound care such as intravenous antibiotics or persistent deep packing for 120 days or longer).

  Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy

Secondary Outcomes (8)

• Local Failure Rate

  Up to 1 year

• Percent Probability of Disease-free Survival at 1 Year

  up to 1 year

• Percent Probability of Overall Survival at 1 Year

  Up to 1 year

• Incidence of Late Adverse Events

  Between 3 months and 24 months after completion of hypofractionated preoperative radiation therapy

• Pattern of Relapse

  Up to 1 years

Study Arms (1)

Treatment (hypofractionated radiation therapy, resection)

EXPERIMENTAL

Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.

Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Resection

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (hypofractionated radiation therapy, resection)

Questionnaire Administration OTHER

Ancillary studies

Treatment (hypofractionated radiation therapy, resection)

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

Treatment (hypofractionated radiation therapy, resection)

Resection PROCEDURE

Undergo surgical resection

Also known as: Surgical Resection

Treatment (hypofractionated radiation therapy, resection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Ahmed SK, Xu-Welliver M, Dorr M, Steinert KO, Houdek MT, Rose PS, Karim SM, Ashman JB, Goulding KA, Siontis BL, Haddock MG, Petersen IA. Hypofractionated Preoperative Radiation Therapy for Extremity and Superficial Trunk Soft Tissue Sarcomas: Results of a Prospective, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2025 Nov 15;123(4):980-989. doi: 10.1016/j.ijrobp.2025.05.006. Epub 2025 May 17.

  PMID: 40389098 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Radiation Dose Hypofractionation; Radiation

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Safia K. Ahmed, MD
• Organization: Mayo Clinic

ahmed.safia@mayo.edu

507-284-2511

Study Officials

• Safia K. Ahmed, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: November 30, 2020
• Primary Completion: October 31, 2024
• Study Completion (Estimated): October 31, 2029
• Last Updated: February 4, 2026
• Results First Posted: January 16, 2026

Record last verified: 2026-01

Locations

US (3)