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A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity
Sponsor: Sarcoma Alliance for Research through Collaboration
Summary
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
Official title: SU2C-SARC032: A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2017-07-19
Completion Date
2028-09-01
Last Updated
2023-11-18
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm.
Locations (20)
University of California Los Angeles
Los Angeles, California, United States
Mayo Clinic- Florida
Jacksonville, Florida, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania- Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh (UPMC Hillman Cancer Center)
Pittsburgh, Pennsylvania, United States
Chris O'Brien Hospital
Camperdown, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
McGill University Health Centre
Montreal, Quebec, Canada
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy