Clinical trial · Interventional
Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk
Prospective Trial of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk (HYPORT-STS)
NCT03819985CI-TRIAL-00104671active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.
Conditions
Conditions (8)
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 IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
| Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
| Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (hypofractionated RT)
- description
- Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Time to a major wound complication (MWC)
- timeFrame
- Up to 120 days after surgery
- description
- A Bayesian approach for the analysis of a stopping rule of higher acute wound complications for the new dose (E) will be employed.
Secondary outcomes (9)
- measure
- Local recurrence free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDBishop AJ, Mitra D, Farooqi A, Swanson DM, Hempel C, Willis T, Pearlnath C, Wang WL, Ratan R, Somaiah N, Benjamin RS, Torres KE, Hunt KK, Scally CP, Keung EZ, Satcher RL, Bird JE, Lin PP, Moon BS, Lewis VO, Roland CL, Guadagnolo BA. Moderately hypofractionated, preoperative radiotherapy in patients with soft tissue sarcomas (HYPORT-STS): Updated local control, late toxicities, and patient-reported outcomes. Cancer. 2025 Jan 1;131(1):e35542. doi: 10.1002/cncr.35542. Epub 2024 Aug 27. PMID 39192597
- DERIVEDGuadagnolo BA, Bassett RL, Mitra D, Farooqi A, Hempel C, Dorber C, Willis T, Wang WL, Ratan R, Somaiah N, Benjamin RS, Torres KE, Hunt KK, Scally CP, Keung EZ, Satcher RL, Bird JE, Lin PP, Moon BS, Lewis VO, Roland CL, Bishop AJ. Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2022 Dec;23(12):1547-1557. doi: 10.1016/S1470-2045(22)00638-6. Epub 2022 Nov 4. PMID 36343656