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ASSG Endorsed Clinical Study


Title 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
Objective Study to compare neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab.
Type This is an open-label, multi-institutional phase II randomized study
Population Patients with clinically localized extremity soft tissue sarcoma at high risk for developing metastatic disease (tumor size > 5 cm, intermediate- to high-grade; approximately 50% risk for distant disease at 2 years). Histologies will be limited to undifferentiated pleomorphic sarcoma and dedifferentiated/pleomorphic liposarcoma based on preliminary data from SARC028. Other terms for undifferentiated pleomorphic sarcoma may include, but are not limited to. pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, spindle cell sarcoma not otherwise specified, pleomorphic spindle cell sarcoma, pleomorphic fibroblastic sarcoma, undifferentiated high-grade pleomorphic sarcoma, pleomorphicsarcoma with prominent inflammation, pleomorphic sarcoma with giant cells, malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes), fibrosarcoma, and myxofibrosarcoma (located deep to the fascia in muscle).
Treatment Neoadjuvant radiotherapy followed by surgical resection or neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab.
Phase II
Drug / Intervention This is a multicenter, randomized phase II trial with an initial safety run-in to test the safety and efficacy of neoadjuvant pembrolizumab with image-guided radiotherapy and adjuvant pembrolizumab compared to radiation therapy alone. Radiation therapy with three cycles of pembrolizumab will be administered as neoadjuvant therapy for patients randomized to the experimental arm. These patients will also receive up to fourteen cycles of adjuvant pembrolizumab after surgical resection. Patients in the standard of care arm will receive neoadjuvant radiotherapy (50 Gy in 25 fractions) followed by surgical resection as in RTOG 0630.
Sponsor Sarcoma Alliance for Research through Collaboration
Australasian Sarcoma Study Group
Funding Source
Target accrual
Expected Completion July 30, 2025
Participating Sites Australian Sites: Chris O'Brien Hospital in NSW, Princess Alexandra Hospital in QLD
Recruitment Status Recruiting
Numbers Accrued
Publications and Presentations
Principal Investigator Chris O'Brien Hospital in NSW: Dr Angela Hong
Princess Alexandra Hospital in QLD: Dr David Pryor
Contact for Further Information; Dr Denise Caruso
Contact Phone Number 1800 177 657
Last update 25-Oct-2018 09:41 AM 


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