Sarcoma Disease Site

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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
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: Open to Accrual
Activation Date: December 05, 2014

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


Open to Accrual
SR4 (SWOG S0033)Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)
Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)

Complexity Level: 2

Eligibility: Patients must have a biopsy proven diagnosis of gastrointestinal stromal tumour (GIST) which is distantly metastatic or unresectable. The primary must be of visceral or intraabdominal origin. All patients must have immunohistochemical documentation of KIT (CD117) expression by tumour documented by DAKO antibody staining. Patients must have an identified team (including a medical oncologist and a surgeon) to provide care.

Objectives: To compare overall and progression-free survival for patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) expressing KIT (CD 117) treated with low dose STI-571 versus high dose STI-571. To assess response rates (confirmed, unconfirmed, complete and partial) and toxicities of patients treated with these two doses of STI-571. To obtain tissue and blood samples from GIST patients before and following treatment with STI-571 for future correlative studies.

NCT Registration ID (from clinicaltrials.gov): NCT00009906
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 10, 2001 Closing Date: September 01, 2001

Chair: (Canada) Dr. Vivien H. Bramwell, Tom Baker Cancer Centre, (403) 521-3707


Closed to Accrual
SRC1 (ACOSOG Z9001)A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumors (GIST)
A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumors (GIST)

Complexity Level: 2

Eligibility: Patient must have a diagnosis of primary GIST confirmed histologially by central pathology review. The patient's tumor must stain positive for the Kit receptor tyrosine kinase on immunohistochemistry as determined by the Central Pathologist using the Dako anti-CD 117 antibody (Dako Corp., Carpinteria, CA). The patient must have undergone complete gross resection (includes R0 [negative microscopic margins] and R1 [positive microscopic margins] resections) of a primary GIST within 70 days prior to registration. Tumor size must be > 3 cm in maximum dimension. Post-operative chemotherapy, radiation therapy or investigational treatment will cause the patient to be ineligible, as will prior therapy with STI-571. Patients will not be eligible for randomization if they have New York Heart Association Class 3 or 4 cardiac disease, or if they are taking full-dose warfarin.

Objectives: To ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer recurrence-free survival and overall survival as compared to the patients randomized to the Placebo Arm. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and if the patient develops recurrence), blood specimens (before therapy with STI571), and serum specimens (before therapy with STI571, after completing therapy with STI571, and if the patient develops recurrence) for scientific correlative analyses. To assess the safety/efficacy of oral STI571 therapy in the adjuvant setting.

NCT Registration ID (from clinicaltrials.gov): NCT00041197
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 04, 2002 Closing Date: April 18, 2007

Closed to Accrual
SRC7 (ALLIANCE A091105)A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)
A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)

Complexity Level: 2

Eligibility: Patients must have confirmation of DT/DF by local pathologist prior to registration. Prior therapies must have been completed at least 4 weeks prior to registration. No prior treatment with sorafenib. No concomitant treatment, in therapeutic doses, with or antiplatelet agents, or with CYP3A4 inhibitors. Patients must have measurable disease and either have unresectable disese, disease progression by radiographic imaging, or symptomatic disease which is BPI score greater than or equal to 3 and unable to control pain with NSAIDs, OR >30% increase in current use of narcotics OR addition of a new opioid narcotic. Patient must be 18 years of age or older, ECOG PS less than or equal to 2, not pregnant or nursing, no history of cardiac disease, no inadequately controlled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, no clinically significant GI bleeding or bleeding diathesis within 30 days of registration, and adequate blood counts.

Objectives: Primary Objective: To compare the progression-free survival (PFS) rates of patients with DT/DF who receive either sorafenib or placebo using a double-blinded randomized phase III study. Secondary Objectives: To assess toxicity, to assess time to surgical intervention, to assess tumor response rates and survival.

NCT Registration ID (from clinicaltrials.gov): NCT02066181
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 17, 2015 Closing Date: December 01, 2016

Closed to Accrual
I136A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma

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

Chair: (Canada) Dr. Donald G. Morris, Tom Baker Cancer Centre, (403) 521-3347


Permanently Closed
I15NCIC CTG Phase II Study of Mitoxantrone in Sarcoma
NCIC CTG Phase II Study of Mitoxantrone in Sarcoma

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
I155A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma
A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

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

Chair: (Canada) Dr. Meg Knowling, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 672017


Permanently Closed
I200A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.
A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.

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

Chair: (Canada) Dr. Quincy Chu, Cross Cancer Institute, (780) 432-8248


Permanently Closed
I28NCIC CTG Phase II Study of Trimetrexate in Sarcoma
NCIC CTG Phase II Study of Trimetrexate in Sarcoma

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
I28ANCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma
NCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma

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
I29NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma
NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma

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
I55NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma
NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma

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
I71NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma
NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma

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
I77NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma
NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma

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
OS1NCIC Osteosarcoma. A Protocol for Clinical Investigation
NCIC Osteosarcoma. A Protocol for Clinical Investigation

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
OS2The Evaluation of Cis-platinum II, Dimminedi-chloroplatinum (DDP) (NSC - 119875) in Patients With Osteosarcoma Unresponsive to Adriamycin and High-Dose Methotrexate
The Evaluation of Cis-platinum II, Dimminedi-chloroplatinum (DDP) (NSC - 119875) in Patients With Osteosarcoma Unresponsive to Adriamycin and High-Dose Methotrexate

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
A Randomized Trial of Two Chemotherapy Regimens in the Treatment of Operable Osteosarcoma - Doxorubicin-Cisplatin vs Methotrexate-Vincristine-Doxorubicin + Doxorubicin-Cisplatin + Bleomycin-Cyclophosphamide-Dactinomycin

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

Chair: (Canada) Dr. Vivien H. Bramwell, Tom Baker Cancer Centre, (403) 521-3707


Permanently Closed
SR1 (E62874)A Randomized Phase II/III Study of Neoadjuvant Chemotherapy In Soft Tissue Sarcomas in Adults
A Randomized Phase II/III Study of Neoadjuvant Chemotherapy In Soft Tissue Sarcomas in Adults

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

Chair: (Canada) Dr. Vivien H. Bramwell, Tom Baker Cancer Centre, (403) 521-3707


Permanently Closed
SR2A 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
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

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

Chair: (Canada) Dr. Brian O'Sullivan, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2125, (Canada) Dr. Vivien H. Bramwell, Tom Baker Cancer Centre, (403) 521-3707


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
Randomized Trial of Adjuvant Chemotherapy with High-dose Doxorubicin, Ifosfamide and Lenograstim (G-CSF) in High Grade Soft Tissue Sarcoma

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

Chair: (Canada) Dr. Vivien H. Bramwell, Tom Baker Cancer Centre, (403) 521-3707


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
Randomized Trial of Single Agent Doxorubicin Vs. Doxorubicin plus Ifosfamide in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma

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

Chair: (Canada) Dr. Stewart Rorke, Dr. H. Bliss Murphy Cancer Centre, (709) 777-7802


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
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

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
A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumours

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

Chair: (Canada) Dr. Karen Mulder, Cross Cancer Institute, (780) 432-8514


Permanently Closed