Recruiting
Phase 3

UHRT-5 vs. RT-25

Sponsor:

SWOG Cancer Research Network

Code:

NCT07615049

Conditions

Recurrent Soft Tissue Sarcoma of the Trunk and Extremities

Resectable Soft Tissue Sarcoma of the Trunk and Extremities

Soft Tissue Sarcoma of the Trunk and Extremities

Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3-Dimensional Conformal Radiation Therapy

3-Dimensional Conformal Radiation Therapy

Biospecimen Collection

Computed Tomography

Intensity-Modulated Radiation Therapy

Study Details

Brief summary:

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.

Conditions

Recurrent Soft Tissue Sarcoma of the Trunk and Extremities

Resectable Soft Tissue Sarcoma of the Trunk and Extremities

Soft Tissue Sarcoma of the Trunk and Extremities

Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Study ID

NCT07615049

Start date

Dec 2, 2026

Status verified date

Oct, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

296 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1 (RT-25)

Patients undergo RT-25 with 3D CRT or IMRT QD for up to 5 fractions per week for 25 fractions over a minimum of 32 calendar days and maximum of 49 days in the absence of disease progression or unacceptable toxicity. Starting 22-56 calendar days after radiation, patients undergo surgical resection. Additionally, patients undergo MRI, CT, and blood sample collection throughout the study.

experimental: Arm 2 (UHRT-5)

Patients undergo UHRT-5 with 3D CRT or IMRT QD for up to 5 fractions per week for 5 fractions over a minimum of 5 calendar days and maximum of 14 days in the absence of disease progression or unacceptable toxicity. Starting 22-56 calendar days after radiation, patients undergo surgical resection. Additionally, patients undergo MRI, CT, and blood sample collection throughout the study.

Interventions

3-Dimensional Conformal Radiation Therapy

Undergo RT-25 with 3D-CRT

3-Dimensional Conformal Radiation Therapy

Undergo UHRT-5 with 3D CRT

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT

Intensity-Modulated Radiation Therapy

Undergo RT-25 with IMRT

Intensity-Modulated Radiation Therapy

Undergo UHRT-5 with IMRT

Magnetic Resonance Imaging

Undergo MRI

Surgical Procedure

Undergo surgical resection

Primary outcome measure

  • Local tumor recurrence rate [ Time Frame: At 2 years ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

gingerreeves@uabmc.edu

Principal Investigator:

Mehran Yusuf

Kaiser Permanente-Anaheim

Recruiting

Anaheim, California, United States, 92806

Contacts

Site Public Contact

800-398-3996clinical.trials@kp.org

Principal Investigator:

Aakash Batra

Kaiser Permanente-Deer Valley Medical Center

Recruiting

Antioch, California, United States, 94531

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Bellflower

Recruiting

Bellflower, California, United States, 90706

Contacts

Site Public Contact

800-398-3996clinical.trials@kp.org

Principal Investigator:

Aakash Batra

Kaiser Permanente Dublin

Recruiting

Dublin, California, United States, 94568

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Fremont

Recruiting

Fremont, California, United States, 94538

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Fresno Cancer Center

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Fresno Orchard Plaza

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

833-574-2273

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Fresno

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Jeremy P. Harris

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Contacts

Site Public Contact

800-398-3996clinical.trials@kp.org

Principal Investigator:

Aakash Batra

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Andrew S. Lim

Kaiser Permanente- Modesto MOB II

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Oakland-Broadway

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Ontario

Recruiting

Ontario, California, United States, 91761

Contacts

Site Public Contact

800-398-3996clinical.trials@kp.org

Principal Investigator:

Aakash Batra

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Jeremy P. Harris

Kaiser Permanente-Rancho Cordova Cancer Center

Recruiting

Rancho Cordova, California, United States, 95670

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente- Marshall Medical Offices

Recruiting

Redwood City, California, United States, 94063

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Richmond

Recruiting

Richmond, California, United States, 94801

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Rohnert Park Cancer Center

Recruiting

Rohnert Park, California, United States, 94928

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Roseville

Recruiting

Roseville, California, United States, 95661

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

The Permanente Medical Group-Roseville Radiation Oncology

Recruiting

Roseville, California, United States, 95678

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Downtown Commons

Recruiting

Sacramento, California, United States, 95814

Contacts

Site Public Contact

877-642-4691kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-South Sacramento

Recruiting

Sacramento, California, United States, 95823

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

South Sacramento Cancer Center

Recruiting

Sacramento, California, United States, 95823

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Santa Teresa-San Jose

Recruiting

San Jose, California, United States, 95119

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente San Leandro

Recruiting

San Leandro, California, United States, 94577

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser San Rafael-Gallinas

Recruiting

San Rafael, California, United States, 94903

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Medical Center - Santa Clara

Recruiting

Santa Clara, California, United States, 95051

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Cancer Treatment Center

Recruiting

South San Francisco, California, United States, 94080

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-South San Francisco

Recruiting

South San Francisco, California, United States, 94080

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Stockton

Recruiting

Stockton, California, United States, 95210

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Medical Center-Vacaville

Recruiting

Vacaville, California, United States, 95688

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Vallejo

Recruiting

Vallejo, California, United States, 94589

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Walnut Creek

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Christiana Care Health System-Christiana Hospital

Recruiting

Newark, Delaware, United States, 19718

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Sibo Tian

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Sibo Tian

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Sibo Tian

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Sibo Tian

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Site Public Contact

800-639-6918cancer.research.nurse@dartmouth.edu

Principal Investigator:

Nirav S. Kapadia

Dartmouth Cancer Center - Manchester/ DCC Manchester

Recruiting

Manchester, New Hampshire, United States, 03104

Contacts

Site Public Contact

603-629-1828

Principal Investigator:

Nirav S. Kapadia

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Site Public Contact

800-767-9355askroswell@roswellpark.org

Principal Investigator:

Varun K. Chowdhry

Montefiore Medical Center-Einstein Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Jana L. Fox

Montefiore Medical Center-Weiler Hospital

Recruiting

The Bronx, New York, United States, 10461

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Jana L. Fox

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Jana L. Fox

Christiana Care Health System-Concord Health Center

Recruiting

Chadds Ford, Pennsylvania, United States, 19317

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Geisinger Medical Oncology-Lewisburg

Recruiting

Lewisburg, Pennsylvania, United States, 17837

Contacts

Site Public Contact

570-523-9200cancerresearch@geisinger.edu

Principal Investigator:

Heath B. Mackley

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Erik S. Blomain

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Heath B. Mackley

Dartmouth Cancer Center - North

Recruiting

Saint Johnsbury, Vermont, United States, 05819

Contacts

Site Public Contact

800-639-6918cancer.research.nurse@hitchcock.org

Principal Investigator:

Nirav S. Kapadia

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Hyun Lee

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Anderson A. Bauer

Froedtert Menomonee Falls Hospital

Recruiting

Menomonee Falls, Wisconsin, United States, 53051

Contacts

Site Public Contact

262-257-5100

Principal Investigator:

Ciani Ellison

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Ciani Ellison

Froedtert and MCW Moorland Reserve Health Center

Recruiting

New Berlin, Wisconsin, United States, 53151

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Ciani Ellison

Drexel Town Square Health Center

Recruiting

Oak Creek, Wisconsin, United States, 53154

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Ciani Ellison

Froedtert West Bend Hospital/Kraemer Cancer Center

Recruiting

West Bend, Wisconsin, United States, 53095

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Ciani Ellison

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Anderson A. Bauer

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.