Testing Short-Course Radiation Versus Standard-Course Radiation for Soft Tissue Sarcomas That Need Surgery and Radiation
Start Date
12/2/2026
Completion Date
4/30/2030
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.
Detailed Description
PRIMARY OBJECTIVE: I. 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: I. 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: I. 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. V. To describe the use of adjuvant therapy post-surgery separately by treatment arm. BANKING OBJECTIVE: I. 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
3-Dimensional Conformal Radiation Therapy
3-Dimensional Conformal Radiation Therapy
Biospecimen Collection
Computed Tomography
Intensity-Modulated Radiation Therapy
Intensity-Modulated Radiation Therapy
Magnetic Resonance Imaging
Surgical Procedure
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Kaiser Permanente-Anaheim
Anaheim, California 92806
United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
United States
Kaiser Permanente-Bellflower
Bellflower, California 90706
United States
Kaiser Permanente Dublin
Dublin, California 94568
United States
Kaiser Permanente-Fremont
Fremont, California 94538
United States
Fresno Cancer Center
Fresno, California 93720
United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California 93720
United States
Kaiser Permanente-Fresno
Fresno, California 93720
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Kaiser Permanente- Modesto MOB II
Modesto, California 95356
United States
Kaiser Permanente Oakland-Broadway
Oakland, California 94611
United States
Kaiser Permanente-Oakland
Oakland, California 94611
United States
Kaiser Permanente-Ontario
Ontario, California 91761
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California 94063
United States
Kaiser Permanente-Richmond
Richmond, California 94801
United States
Rohnert Park Cancer Center
Rohnert Park, California 94928
United States
Kaiser Permanente-Roseville
Roseville, California 95661
United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
United States
Kaiser Permanente Downtown Commons
Sacramento, California 95814
United States
Kaiser Permanente-South Sacramento
Sacramento, California 95823
United States
South Sacramento Cancer Center
Sacramento, California 95823
United States
Kaiser Permanente-San Francisco
San Francisco, California 94115
United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
United States
Kaiser Permanente San Leandro
San Leandro, California 94577
United States
Kaiser San Rafael-Gallinas
San Rafael, California 94903
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
United States
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
United States
Kaiser Permanente-Stockton
Stockton, California 95210
United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
United States
Kaiser Permanente-Vallejo
Vallejo, California 94589
United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
United States
Grady Health System
Atlanta, Georgia 30303
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Dartmouth Cancer Center - Manchester/ DCC Manchester
Manchester, New Hampshire 03104
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York 10461
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin 53151
United States
Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
United States
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States