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Sarcoma Disease Site

Sarcoma

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SRC8 (ECOG-ACRIN EA7222)

A Randomized Phase III Trial of Doxorubicin + Pembrolizumab versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas


Complexity Level: 2

Eligibility: Patient must be ≥ 18 years of age. Must have a confirmed histopathologic diagnosis of Undifferentiated Pleomorphic Sarcoma (UPS) or a related poorly differentiated sarcoma. must have metastatic or unresectable sarcoma. Patient must have an ECOG Performance Status 0-1.

Objectives: PRIMARY:To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone. SECONDARY:To assess whether the combination of doxorubicin and pembrolizumab vs the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression (i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival (OS). -To evaluate the safety and tolerability in each treatment arm -To quantify overall response rate (ORR) and durability of response (DOR) in each treatment.

NCT Registration ID (from clinicaltrials.gov): NCT06422806
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Planned

Chair: (Canada) Dr. Shantanu Banerji, CancerCare Manitoba, (204) 787-8959


Planned
SR7 (EORTC 1809-STBSG)

A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery versus Surgery Alone for Patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

This is a randomized, multicentre, open-label phase III trial of neoadjuvant chemotherapy followed by surgery versus surgery alone in patients with RPS. The randomization will be stratified by institution and histology: liposarcoma LPS or leyomiosarcoma (LMS). Patients will be randomized to either Standard arm: large en-bloc curative intent surgery or Experimental arm: 3 cycles of neoadjuvant chemotherapy followed by curative intent surgery. The primary endpoint of the study is disease free survival which includes as events: distant progression on neoadjuvant treatment, local progression if not followed by R0/R1 surgery, non-operable tumours, local recurrence and/or distant metastases, R2 and death.


Complexity Level: 2

Eligibility: Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis, unifocal resectable tumour, radiologically measurable disease (RECIST 1.1), 18 years old or older, WHO ps 0-2, adequate haematological and organ function, ASA < 3, negative serum pregnancy test, consent to use highly effective birth control measures throughout duration of study and for at least 6 months after last treatment. No sarcoma originating from bone structure, abdominal or gynecological viscera, no metastatic disease, no previous treatment to present tumour, no hypersensitivity to doxorubicin, ifosfamide, dacarbazine or any of their metabolites/excipients, no recent or uncontrolled cardiac disease, no active or uncontrolled infections, and/or no live vaccines within 30 days of study entry.

Objectives: The primary objective of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of patients with high risk de-differentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) as measured by disease-free survival.

NCT Registration ID (from clinicaltrials.gov): NCT04031677
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: February 01, 2021

Chair: (Canada) Dr. Rebecca Gladdy, Sinai Health System, (416) 586-8440


Open to Accrual
SRC6 (COG ARST1321)

Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib


Complexity Level: 2

Eligibility: Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk. Patients must be 2 years or older at the time of the biopsy that established the diagnosis of NRSTS.

Objectives: Primary:Determine feasibility of pazopanib + radiation or chemoradiation (phase II. Compare rates of complete pathologic response in patients receiving radiation or chemoradiation +/- pazopanib (phase II).Compare rates of EFS in patients receiving radiation +/- pazopanib (phase III) Secondary: Estimate and compare rates of local, regional and distant failure, DFS and OS. Compare patterns of recurrence. Define toxicities of pazopanib in combination with radiation or chemoradiation.

NCT Registration ID (from clinicaltrials.gov): NCT02180867
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: December 05, 2014 Closing Date: October 22, 2018

Chair: (Canada) Dr. Mohamed A.M. Akra, CancerCare Manitoba, (204) 787-1210


Closed to Accrual