Shorter radiation course vs standard course for soft tissue sarcoma of the limb/trunk
Official title: Phase III Randomized Study Testing Non-Inferiority of Short-Course Ultra-Hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) for Stage II-IIIB, Extremity, Resectable Soft Tissue Sarcoma
Run by SWOG Cancer Research Network · NCT07615049 · Data updated 2026-11-12
This trial tests whether a 5-day, ultrahypofractionated radiation therapy approach works as well as the standard 25-day course for soft tissue sarcoma that can be surgically removed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 296 (estimated) |
| Sponsor | SWOG Cancer Research Network Research network |
| Drugs / interventions | radiation |
| Locations | 67 sites (Birmingham, Alabama and 66 other locations) |
| Status | Recruiting |
| Started | December 2, 2026 |
| Main results expected | April 30, 2029 |
| Study ends | April 30, 2030 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07615049 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Candidates are adults with histologically confirmed soft tissue sarcoma of the trunk or extremities, stage II–IIIB by AJCC 8th edition, resectable, and either primary or locally recurrent.
✕Probably not a fit
Patients with non-resectable disease, tumors outside the trunk/extremities, or those who do not meet imaging/biopsy criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with high-risk soft tissue sarcoma of the trunk or limbs that is resectable are randomized to receive either a short-course radiation therapy over 5 days or the standard course over 25 days, both planned around surgical removal of the tumor. The study uses advanced radiation techniques to maximize tumor dose while sparing healthy tissue. Outcomes include local recurrence at 2 years, wound and late radiation-related complications, functional status, and survival metrics. Exploratory analyses look at per-protocol recurrence, wound healing, surgical margins, and post-surgery therapies. Tissue banking is included for future correlative studies.
Why it matters
Potential benefit: If successful, patients could benefit from a shorter radiation schedule without compromising tumor control or function.
How similar studies have gone: Previous studies in similar settings have explored shorter regimens with mixed results; this trial provides a rigorous comparison in a high-risk, resectable cohort.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have histological evidence of a soft tissue sarcoma from core or incisional biopsy. Participants must have a primary or locally recurrent tumor. Stage II-IIIB (by American Joint Committee on Cancer \[AJCC\] 8th edition) soft tissue sarcoma is required * Prior partial excision or partial excisional biopsy of the tumor, with imaging evidence of gross residual disease \> 1cm in longest dimension (stage II-IIIB) * Participants must have a primary site of disease in the extremity, including the shoulder girdle and hip girdle but excluding the hands and feet * Participants with primary sites of trunk, head, neck, or intra-abdominal, intrapelvic, or retroperitoneal region are not eligible * Participants with extension of the primary tumor into adjacent regions (e.g. torso, hands, feet) are eligible * Participants must have an MRI of the primary site within 90 days prior to randomization. The MRI field of view must contain the entirety of the tumor (may be accomplished with multiple MRI scans). MRI must contain axial acquired T1 weighted with fat suppression, T1 weighted sequence with gadolinium contrast with fat suppression, and T2 weighted fat suppression sequence * Participants must have no evidence of metastatic disease by CT imaging of the chest (or positron emission tomography \[PET\] CT), within 28 days before randomization * Given the lack of specificity of chest CT, pulmonary nodule(s) ≤ 5 mm without a histological diagnosis are not exclusionary * Participants with pulmonary nodule(s) measuring 6-10 mm on chest CT are eligible if the nodules appear stable compared to prior chest imaging from at least 6 months ago, or if an fludeoxyglucose F-18 (18FDG)-PET scan indicates that the nodules are unlikely to be metastatic disease * Pulmonary nodules \> 10 mm should be considered metastatic unless proven otherwise by biopsy/resection or stable appearance for at least 6 months on imaging * Participants must not have fungating tumor. (i.e., tumor breakthrough of skin) * Participants must not have myxoid liposarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma, gastrointestinal stromal tumor, osteosarcoma, neurotrophic tyrosine receptor kinase (NTRK)-rearranged spindle cell neoplasm, desmoplastic small round cell tumor, Ewing sarcoma, or sarcoma arising from bone * Participants must not have known brain metastases. Brain imaging studies are not required for eligibility if the participant has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease * Participants must have been evaluated by a surgeon, and it must have been determined that they are a good candidate for a limb salvage resection with an expectation of negative margins, within 35 days prior to randomization. Anticipated positive margins on fixed critical structures are allowed * Participants must not have had prior treatment for the current tumor (systemic therapy, radiation, or complete surgical resection) * Participants must not have had prior radiation to the anatomical site * Participants must be ≥ 18 years old at the time of randomization * Participants must have Zubrod performance status of 0-2 * Participants must have medical history and physical exam within 28 days prior to randomization. History and physical examination must include a description of the location of the tumor, including lateralization and extremity * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must not have uncontrolled intercurrent illnesses or any other significant condition(s) that would make this protocol unreasonably hazardous * Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration * Participants registered by sites located in the United States only must be offered the opportunity to participate in specimen banking * NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Where it's running
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States Recruiting -
Kaiser Permanente-Anaheim
Anaheim, California, United States Recruiting -
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States Recruiting -
Kaiser Permanente-Bellflower
Bellflower, California, United States Recruiting -
Kaiser Permanente Dublin
Dublin, California, United States Recruiting -
Kaiser Permanente-Fremont
Fremont, California, United States Recruiting
Show 44 more locations
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Fresno Cancer Center
Fresno, California, United States Recruiting -
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States Recruiting -
Kaiser Permanente-Fresno
Fresno, California, United States Recruiting -
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States Recruiting -
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States Recruiting -
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States Recruiting -
Kaiser Permanente- Modesto MOB II
Modesto, California, United States Recruiting -
Kaiser Permanente Oakland-Broadway
Oakland, California, United States Recruiting -
Kaiser Permanente-Oakland
Oakland, California, United States Recruiting -
Kaiser Permanente-Ontario
Ontario, California, United States Recruiting -
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States Recruiting -
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States Recruiting -
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, United States Recruiting -
Kaiser Permanente-Richmond
Richmond, California, United States Recruiting -
Rohnert Park Cancer Center
Rohnert Park, California, United States Recruiting -
Kaiser Permanente-Roseville
Roseville, California, United States Recruiting -
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States Recruiting -
Kaiser Permanente Downtown Commons
Sacramento, California, United States Recruiting -
Kaiser Permanente-South Sacramento
Sacramento, California, United States Recruiting -
South Sacramento Cancer Center
Sacramento, California, United States Recruiting -
Kaiser Permanente-San Francisco
San Francisco, California, United States Recruiting -
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States Recruiting -
Kaiser Permanente San Leandro
San Leandro, California, United States Recruiting -
Kaiser San Rafael-Gallinas
San Rafael, California, United States Recruiting -
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States Recruiting -
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States Recruiting -
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States Recruiting -
Kaiser Permanente-South San Francisco
South San Francisco, California, United States Recruiting -
Kaiser Permanente-Stockton
Stockton, California, United States Recruiting -
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States Recruiting -
Kaiser Permanente-Vallejo
Vallejo, California, United States Recruiting -
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States Recruiting -
Helen F Graham Cancer Center
Newark, Delaware, United States Recruiting -
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States Recruiting -
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States Recruiting -
Grady Health System
Atlanta, Georgia, United States Recruiting -
Emory University Hospital Midtown
Atlanta, Georgia, United States Recruiting -
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States Recruiting -
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States Recruiting -
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States Recruiting -
Decatur Memorial Hospital
Decatur, Illinois, United States Recruiting -
Billings Clinic Cancer Center
Billings, Montana, United States Recruiting -
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States Recruiting -
Dartmouth Cancer Center - Manchester/ DCC Manchester
Manchester, New Hampshire, United States Recruiting
+17 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Jeremy P Harris — SWOG Cancer Research Network
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing limited and intense follow-up care for patients with stage II-III soft tissue sarcoma
This study is testing whether more frequent follow-up visits or fewer visits after surgery can help reduce anxiety and improve outcomes for patients with stage II-III soft tissue sarcoma.
-
Moderately Hypofractionated Neoadjuvant Radiotherapy for Soft Tissue Sarcoma of the Limbs or Trunk Wall
This trial tests whether giving a shorter course of radiotherapy before surgery helps control soft tissue sarcoma in the limbs or trunk without waiting longer.
-
Personalised neoadjuvant therapy planning for adults with high‑risk soft tissue sarcoma
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-
Dose‑escalated, short‑course proton radiation for inoperable soft tissue sarcoma
This will try higher-dose, shorter-course proton radiation to see if it controls tumors better in adults with inoperable soft tissue sarcoma.
-
Three-week preoperative proton versus X-ray radiotherapy for localized soft tissue sarcoma
This trial tests whether selecting proton rather than standard X‑ray radiotherapy before surgery for adults with localized soft tissue sarcoma can lower long-term radiation side effects without increasing surgical complications.
-
Fluorescence-guided surgery to optimize sarcoma margins
This will try using an injected fluorescent dye (ICG) during surgery to see if it reduces positive margins and reoperations for adults having curative surgery for intermediate-to-high grade soft tissue sarcoma of the trunk or limbs.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.