NCT03819985

Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk

Active, enrolled Phase 2 Last updated 5 March 2026

What this trial tests

Phase 2 trial testing Hypofractionated Radiation Therapy in Resectable Soft Tissue Sarcoma in 122 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 December 2018

Primary endpoint
31 August 2027

31 August 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	17 December 2018
Primary completion	31 August 2027
Estimated completion	31 August 2027
Sites	1 location across United States

Drugs / interventions tested

• Hypofractionated Radiation Therapy — full drug profile →
• Quality-of-Life Assessment
• Questionnaire Administration

Conditions studied

• Resectable Soft Tissue Sarcoma — all drugs for Resectable Soft Tissue Sarcoma →
• Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 — all drugs for Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 →
• Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 — all drugs for Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 →
• Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 — all drugs for Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Resectable Soft Tissue Sarcoma or Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial.
   Guadagnolo BA, Bassett RL, Mitra D, Farooqi A, et al · · 2022 · cited 54× · PMID 36343656 · DOI 10.1016/s1470-2045(22)00638-6
2. Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review.
   Roohani S, Ehret F, Kobus M, Flörcken A, et al · · 2022 · cited 25× · PMID 36104789 · DOI 10.1186/s13014-022-02072-9
3. Radiation Therapy in Adult Soft Tissue Sarcoma-Current Knowledge and Future Directions: A Review and Expert Opinion.
   Roeder F. · · 2020 · cited 22× · PMID 33153100 · DOI 10.3390/cancers12113242
4. Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma.
   Valle LF, Bernthal N, Eilber FC, Shabason JE, et al · · 2021 · cited 9× · PMID 34720663 · DOI 10.1155/2021/3735874
5. How Technology Is Improving the Multidisciplinary Care of Sarcoma.
   Schaefer IM, Hong K, Kalbasi A. · · 2020 · cited 7× · PMID 32421448 · DOI 10.1200/edbk_280729
6. Moderately hypofractionated, preoperative radiotherapy in patients with soft tissue sarcomas (HYPORT-STS): Updated local control, late toxicities, and patient-reported outcomes.
   Bishop AJ, Mitra D, Farooqi A, Swanson DM, et al · · 2025 · cited 6× · PMID 39192597 · DOI 10.1002/cncr.35542