NCT07615049RecruitingPhase 3
Testing Short-Course Radiation Versus Standard-Course Radiation for Soft Tissue Sarcomas That Need Surgery and Radiation
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
This clinical trial compares the effect of short-course ultrahypofractionated radiation therapy over 5 days (UHRT-5) to standard-course radiation therapy over 25 days (RT-25) in treating patients with soft tissue sarcomas of the extremities that may be primary or that may have come back to nearby tissue or lymph nodes after a period of improvement (locally recurrent) and that can be removed by surgery (resectable). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. 3-dimensional (3D) conformal radiation therapy (CRT) uses a computer to create a 3D picture of the tumor. This allows doctors to give the highest possible dose of radiation to the tumor, while sparing the normal tissue as much as possible. Intensity-modulated radiation therapy (IMRT) is a type of 3D radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Standard-course (fractionated) radiation divides the total dose of radiation therapy into several smaller, equal doses delivered over a period of several days. Ultrahypofractionated 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. Giving UHRT-5 may be as effective as RT-25 in treating patients with primary or locally recurrent soft tissue sarcomas of the extremities that are resectable. It may also improve quality of life by requiring fewer treatments.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 296 (estimated)
- First submitted
- 11 May 2026
- Start date
- 2 Dec 2026
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- SWOG Cancer Research Network
- Diseases
- Sarcoma
- NCT number
- NCT07615049
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 296
- From 2 Dec 2026 to the primary completion date, 30 Apr 2029
- 67 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (67)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaiser Permanente-Anaheim Coordinator of this site? Confirm its status | Anaheim | United States | Recruiting |
| Kaiser Permanente-Deer Valley Medical Center Coordinator of this site? Confirm its status | Antioch | United States | Recruiting |
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Kaiser Permanente-Bellflower Coordinator of this site? Confirm its status | Bellflower | United States | Recruiting |
| Billings Clinic Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Recruiting |
| University of Alabama at Birmingham Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Christiana Care Health System-Concord Health Center Coordinator of this site? Confirm its status | Chadds Ford | United States | Recruiting |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Kaiser Permanente Dublin Coordinator of this site? Confirm its status | Dublin | United States | Recruiting |
| Kaiser Permanente-Fremont Coordinator of this site? Confirm its status | Fremont | United States | Recruiting |
| Kaiser Permanente-Fresno Coordinator of this site? Confirm its status | Fresno | United States | Recruiting |
| Kaiser Permanente Fresno Orchard Plaza Coordinator of this site? Confirm its status | Fresno | United States | Recruiting |
| Fresno Cancer Center Coordinator of this site? Confirm its status | Fresno | United States | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| Geisinger Medical Oncology-Lewisburg Coordinator of this site? Confirm its status | Lewisburg | United States | Recruiting |
| Kaiser Permanente Los Angeles Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Dartmouth Cancer Center - Manchester/ DCC Manchester Coordinator of this site? Confirm its status | Manchester | United States | Recruiting |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| Froedtert Menomonee Falls Hospital Coordinator of this site? Confirm its status | Menomonee Falls | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Kaiser Permanente- Modesto MOB II Coordinator of this site? Confirm its status | Modesto | United States | Recruiting |
| Christiana Care Health System-Christiana Hospital Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Medical Oncology Hematology Consultants PA Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center Coordinator of this site? Confirm its status | New Berlin | United States | Recruiting |
| Drexel Town Square Health Center Coordinator of this site? Confirm its status | Oak Creek | United States | Recruiting |
| Kaiser Permanente Oakland-Broadway Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Kaiser Permanente-Oakland Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Kaiser Permanente-Ontario Coordinator of this site? Confirm its status | Ontario | United States | Recruiting |
| UC Irvine Health- Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Kaiser Permanente-Rancho Cordova Cancer Center Coordinator of this site? Confirm its status | Rancho Cordova | United States | Recruiting |
| Kaiser Permanente- Marshall Medical Offices Coordinator of this site? Confirm its status | Redwood City | United States | Recruiting |
| Kaiser Permanente-Richmond Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Rohnert Park Cancer Center Coordinator of this site? Confirm its status | Rohnert Park | United States | Recruiting |
| The Permanente Medical Group-Roseville Radiation Oncology Coordinator of this site? Confirm its status | Roseville | United States | Recruiting |
| Kaiser Permanente-Roseville Coordinator of this site? Confirm its status | Roseville | United States | Recruiting |
| Kaiser Permanente-South Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| South Sacramento Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Kaiser Permanente Downtown Commons Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Dartmouth Cancer Center - North Coordinator of this site? Confirm its status | Saint Johnsbury | United States | Recruiting |
| Kaiser Permanente-San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Kaiser Permanente-Santa Teresa-San Jose Coordinator of this site? Confirm its status | San Jose | United States | Recruiting |
| Kaiser Permanente San Leandro Coordinator of this site? Confirm its status | San Leandro | United States | Recruiting |
| Kaiser San Rafael-Gallinas Coordinator of this site? Confirm its status | San Rafael | United States | Recruiting |
| Kaiser Permanente Medical Center - Santa Clara Coordinator of this site? Confirm its status | Santa Clara | United States | Recruiting |
| Kaiser Permanente-Santa Rosa Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| Kaiser Permanente Cancer Treatment Center Coordinator of this site? Confirm its status | South San Francisco | United States | Recruiting |
| Kaiser Permanente-South San Francisco Coordinator of this site? Confirm its status | South San Francisco | United States | Recruiting |
| Kaiser Permanente-Stockton Coordinator of this site? Confirm its status | Stockton | United States | Recruiting |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Montefiore Medical Center-Weiler Hospital Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Kaiser Permanente Medical Center-Vacaville Coordinator of this site? Confirm its status | Vacaville | United States | Recruiting |
| Kaiser Permanente-Vallejo Coordinator of this site? Confirm its status | Vallejo | United States | Recruiting |
| Kaiser Permanente-Walnut Creek Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center Coordinator of this site? Confirm its status | West Bend | United States | Recruiting |
| Marshfield Medical Center - Weston Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.