Clinical trial · Interventional
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
NCT04562480CI-TRIAL-00102379active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Soft Tissue Sarcoma | Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
| Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
| Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
| Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (hypofractionated radiation therapy, resection)
- description
- 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.
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Resection
Primary outcomes (1)
- measure
- Major Wound Complications
- timeFrame
- Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTAhmed 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