Clinical trial Recruiting at 67 sites Phase 3 Interventional Ages 18 and up

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment296 (estimated)
SponsorSWOG Cancer Research Network
Research network
Drugs / interventionsradiation
Locations67 sites (Birmingham, Alabama and 66 other locations)
StatusRecruiting
StartedDecember 2, 2026
Main results expectedApril 30, 2029
Study endsApril 30, 2030
Registry record updatedOctober 13, 2026
Trial IDNCT07615049 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

  • 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
  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.