Sarcoma Disease Site

Sarcoma

ID Sort	Study Title	Status Sort
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. Read More 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 Read More 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
I136	A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): NCT00005974 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 04, 2000 Closing Date: March 06, 2001	Permanently Closed
I15	NCIC CTG Phase II Study of Mitoxantrone in Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 03, 1984 Closing Date: December 09, 1985	Permanently Closed
I155	A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma Read More Eligibility: Patients with histologically documented metastatic or locally advanced soft tissue sarcoma that is not curable by other means. Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is permitted. Objectives: To assess the efficacy & toxicity of perifosine given by mouth for 3 weeks every 4 weeks in patients with untreated, metastatic or locally advanced soft tissue sarcoma. progression rate, and, if responses are observed, response duration. NCT Registration ID (from clinicaltrials.gov): NCT00053794 Participation: Limited to invited centres only. NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 15, 2003 Closing Date: August 10, 2004	Permanently Closed
I200	A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas. Read More Complexity Level: 2 Eligibility: Patients with histologically diagnosed translocation-associated sarcoma. Patients must have measurable disease. A tissue block from primary or metastatic tumour must be available for confirmation of diagnosis, translocation subtype and correlative studies. Up to 1 prior chemotherapy regimen in the metastatic setting is permitted. Prior radiation permitted. No pathologic cardiac arrhythmia within previous 12 months or myocardial infarction within 6 months. Acceptable end-organ function. ECOG 0, 1 or 2. Objectives: To determine the efficacy (as measured by objective response) of SB939 when given orally every other day 3 times a week, in patients with translocation-associated sarcomas. To determine response duration, stable disease rate and progression free survival in these patients. To determine the tolerability and toxicity of SB939 in this population. To explore potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue. NCT Registration ID (from clinicaltrials.gov): NCT01112384 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 18, 2010 Closing Date: January 25, 2012	Permanently Closed
I28	NCIC CTG Phase II Study of Trimetrexate in Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 28, 1986 Closing Date: December 31, 1987	Permanently Closed
I28A	NCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 25, 1988 Closing Date: January 09, 1989	Permanently Closed
I29	NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 21, 1986 Closing Date: November 03, 1987	Permanently Closed
I55	NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 04, 1990 Closing Date: March 06, 1992	Permanently Closed
I71	NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 08, 1992 Closing Date: February 04, 1994	Permanently Closed
I77	NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 28, 1994 Closing Date: June 30, 1995	Permanently Closed
OS1	NCIC Osteosarcoma. A Protocol for Clinical Investigation Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 23, 1976 Closing Date: November 11, 1980	Permanently Closed
OS2	The Evaluation of Cis-platinum II, Dimminedi-chloroplatinum (DDP) (NSC - 119875) in Patients With Osteosarcoma Unresponsive to Adriamycin and High-Dose Methotrexate Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 10, 1978 Closing Date: May 01, 1980	Permanently Closed
OS4 (80861)	A Randomized Trial of Two Chemotherapy Regimens in the Treatment of Operable Osteosarcoma - Doxorubicin-Cisplatin vs Methotrexate-Vincristine-Doxorubicin + Doxorubicin-Cisplatin + Bleomycin-Cyclophosphamide-Dactinomycin Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: September 02, 1986 Closing Date: March 15, 1993	Permanently Closed
SR1 (E62874)	A Randomized Phase II/III Study of Neoadjuvant Chemotherapy In Soft Tissue Sarcomas in Adults Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: September 12, 1989 Closing Date: February 01, 1994	Permanently Closed
SR2	A Phase III Study of Pre-Operative External Beam Radiotherapy Compared to Post-Operative External Beam Radiotherapy in the Local Management of Curable Extremity Soft Tissue Sarcoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 21, 1994 Closing Date: December 12, 1997	Permanently Closed
SR3 (EORTC 62931)	Randomized Trial of Adjuvant Chemotherapy with High-dose Doxorubicin, Ifosfamide and Lenograstim (G-CSF) in High Grade Soft Tissue Sarcoma Read More Complexity Level: 2 Eligibility: Patients with histologically proven high grade soft tissue sarcoma (grade II or III) with no evidence of metastases. Objectives: To compare the effect of treatment with ifosfamide and high dose doxorubicin with filgrastim versus observation on overall survival and relapse free survival. NCT Registration ID (from clinicaltrials.gov): NCT00002641 Participation: Not limited NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: October 05, 1999 Closing Date: December 15, 2003	Permanently Closed
SR5 (62012)	Randomized Trial of Single Agent Doxorubicin Vs. Doxorubicin plus Ifosfamide in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma Read More Complexity Level: 2 Eligibility: Patients with advanced or metastatic soft tissue sarcoma (FNLCC grades 2-3) with RECIST measurable lesions and at least 6 months since adjuvant chemotherapy and PS < 1 (WHO). Objectives: Overall survival; Response, toxicity and treatment related mortality. NCT Registration ID (from clinicaltrials.gov): NCT00061984 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: July 03, 2007 Closing Date: May 11, 2010	Permanently Closed
SR6 (TH-CR-406 / SARC021)	A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma Read More Complexity Level: 2 Eligibility: Male or female 15 years of age or older, has provided informed consent to participate, has pathologically confirmed diagnosis of soft tissue sarcoma for which doxorubicin is appropriate single agent therapy (see main protocol for details), disease is locally advanced unresectable or metastatic with no standard curative therapy available, measurable disease by RECIST 1.1 criteria, ECOG PS of 0 or 1, recovered from prior therapy, life expectancy of at least 3 months, acceptable blood test results for liver, renal and bone marrow function, acceptable cardiac function, must agree to use contraception. Objectives: PRIMARY OBJECTIVES: To evaluate the efficacy and safety of TH-302 in combination with doxorubicin as determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy (neoadjuvant and adjuvant chemotherapy permitted) compared with doxorubicin alone. SECONDARY OBJECTIVES: To evaluate the efficacy of TH-302 in combination with doxorubicin as determined by progression-free survival and response rate in subjects; to investigate the pharmacokinetics of TH-302, Br-IPM, doxorubicin and doxorubicinol in plasma. TERTIARY OBJECTIVES: to evaluate the efficacy of TH-302 in combination with doxorubicin as determined by overall survival at 6 and 12 months, progression free rate at 3 and 6 months, duration of response, stable disease or better rate, change in ECOG and performance status; to explore and compare quality of life and derive health state utilities. NCT Registration ID (from clinicaltrials.gov): NCT01440088 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: July 20, 2012 Closing Date: December 26, 2013	Permanently Closed
SRC5 (S0502)	A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumours Read More Eligibility: Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST) that is distantly metastatic or unresectable. Patients must be determined to be unresectable for cure. Objectives: Progression free survival; Economic; Correlative Biology. NCT Registration ID (from clinicaltrials.gov): NCT00324987 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: April 15, 2009 Closing Date: September 17, 2009	Permanently Closed

Recently Activated Trials

Planned Trials

AL6

ALC7

ALC8

ALC9

BR37

BR38

Sarcoma

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