Recurrent Soft Tissue Sarcoma of the Trunk and ExtremitiesPhase 3NCT07615049
Testing Short-Course Radiation Versus Standard-Course Radiation for Soft Tissue Sarcomas That Need Surgery and Radiation
A Phase 3 study testing 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection and Computed Tomography in people with Recurrent Soft Tissue Sarcoma of the Trunk and Extremities and Resectable Soft Tissue Sarcoma of the Trunk and Extremities, run by SWOG Cancer Research Network at 67 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 67 sitesUnited States
- Study dates
- 2 Dec 2026to 30 Apr 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
67 sites in 1 country. Contact the study team or a site near you to ask about taking part.
67 sites in 1 country
United States67 sites, 67 recruiting
- Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Aakash Batra
- Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-778-1868
Sibo Tian
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Sibo Tian
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Sibo Tian
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Sibo Tian
- Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Aakash Batra
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Mehran Yusuf
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Varun K. Chowdhry
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Fresno Cancer Center
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Site Public Contact, 833-574-2273
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Jeremy P. Harris
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Nirav S. Kapadia
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu
Heath B. Mackley
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Aakash Batra
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Andrew S. Lim
- Recruiting
Dartmouth Cancer Center - Manchester/ DCC Manchester
Manchester, New Hampshire, 03104
Site Public Contact, 603-629-1828
Nirav S. Kapadia
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Anderson A. Bauer
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Ciani Ellison
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Ciani Ellison
- Recruiting
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356
Site Public Contact, 877-642-4691
Samantha A. Seaward
- Recruiting
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Site Public Contact, 414-805-0505
Ciani Ellison
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Ciani Ellison
- Recruiting
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Ontario
Ontario, California, 91761
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Aakash Batra
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Jeremy P. Harris
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Erik S. Blomain
- Recruiting
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063
Site Public Contact, 877-642-4691
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Richmond
Richmond, California, 94801
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Hyun Lee
- Recruiting
Rohnert Park Cancer Center
Rohnert Park, California, 94928
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Roseville
Roseville, California, 95661
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
Site Public Contact, 877-642-4691, kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
South Sacramento Cancer Center
Sacramento, California, 95823
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org
Nirav S. Kapadia
- Recruiting
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente San Leandro
San Leandro, California, 94577
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Stockton
Stockton, California, 95210
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Jana L. Fox
- Recruiting
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Jana L. Fox
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Jana L. Fox
- Recruiting
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Ciani Ellison
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Anderson A. Bauer
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Heath B. Mackley
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate whether the incidence of local tumor recurrence at 2-years after randomization with short-course radiation is non-inferior to standard-course radiation among participants with high-risk, resectable soft tissue sarcoma.
SECONDARY OBJECTIVES:
- To estimate and compare between arms the incidence of acute wound complications.
II. To estimate and compare between arms the incidence of late-term complications associated with radiation at 2-years post-surgery.
III. To estimate and compare between arms changes in physician-assessed functional outcome from pre-randomization to 12 and 24 months post surgery using the Musculoskeletal Tumor Society Scoring system.
IV. To estimate and compare between arms overall survival, progression-free survival, and distant-metastasis-free survival measured from randomization.
EXPLORATORY OBJECTIVES:
- To estimate and compare between arms the incidence of local tumor recurrence at 2 years using a per-protocol analysis.
II. To estimate and compare between arms the incidence of delayed wound healing.
III. To report the type of surgical resection by treatment arm, including limb-salvage versus amputation and margin status (R0, R1, or R2).
IV. To describe the use of supportive therapy medications given with radiation therapy separately by treatment arm.
- To describe the use of adjuvant therapy post-surgery separately by treatment arm.
BANKING OBJECTIVE:
- To bank tissue specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo RT-25 with 3D CRT or IMRT once daily (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 magnetic resonance imaging (MRI), computed tomography (CT), and blood sample collection throughout the study.
ARM 2: 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.
After completion of study treatment, patients are followed up at 4 months, every 6 months after surgery for up to 5 years, and then annually for up to 10 years after randomization.
- 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
- Being tested
- 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection, Computed Tomography, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Dimensional Conformal Radiation TherapyRadiation
Also called 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT
Undergo RT-25 with 3D-CRT
3-Dimensional Conformal Radiation TherapyRadiation
Also called 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT
Undergo UHRT-5 with 3D CRT
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo RT-25 with IMRT
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo UHRT-5 with IMRT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (RT-25) | Active comparator | 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. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Procedure: Surgical Procedure |
| Arm 2 (UHRT-5) | Experimental | 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. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor recurrence rate
Cumulative incidence of local tumor recurrence will be estimated non-parametrically with death from any cause analyzed as a competing risk. 2-year estimates of local tumor recurrence and standard errors will be calculated and used to calculate a one-sided 95% confidence internal for the difference in 2-year local tumor recurrence rates.
Measured: At 2 years
Secondary outcomes (6)
Incidence of acute wound complications
Will be estimated in each arm with 95% exact confidence intervals and compared using Fisher's exact test.
Measured: Up to 4 months after surgery
Incidence of late-term complications associated with radiation
Will be estimated in each arm with 95% exact confidence intervals and compared using Fisher's exact test.
Measured: Up to 2 years post-surgery
Changes in physician-assessed functional outcome
Will be evaluated using the Musculoskeletal Tumor Society Scoring system.
Measured: From pre-randomization up to 24 months post-surgery
Overall survival
Will be estimated in each arm and compared using log-rank tests.
Measured: From randomization up to 10 years
Progression-free survival
Will be estimated in each arm and compared using log-rank tests.
Measured: From randomization up to 10 years
Distant-metastasis-free survival
Cumulative incidence will be estimated non-parametrically in each arm and compared using Gray's test.
Measured: From randomization up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start2 Dec 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Soft Tissue Sarcoma of the Trunk and ExtremitiesStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeremy P Harris, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615049
- Sponsor's protocol ID
- S2505
- Other IDs
- NCI-2026-02587, S2505, S2505, U10CA180888
- Status last verified
- Oct 2026
- First submitted
- 11 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No