Spots Global Cancer Trial Database for Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
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Trial Identification
Brief Title: Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Official Title: A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Study ID: NCT00239980
Conditions
Interventions
Study Description
Brief Summary: Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term survival is poor for the majority of women with EOC because many present with advanced disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in survival and is associated with unacceptable toxicity. This phase II, dose-finding, open label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3 doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based chemotherapy. The primary outcome is disease response, measured according to Gynaecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin associated with the best response will be tested further in a phase III randomized clinical trial in the same patient population.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Cross Cancer Institute, Edmonton, Alberta, Canada
B.C. Cancer Agency- Fraser Valley Centre, Surrey, British Columbia, Canada
B.C. Cancer Agency- Vancouver Centre, Vancouver, British Columbia, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Notre-Dame, Montreal, Quebec, Canada
Contact Details
Name: Laurie Elit, MD
Affiliation: Juravinski Cancer Centre
Role: STUDY_CHAIR
Name: Agnes Lee, MD
Affiliation: Hamilton Health Sciences Henderson Division
Role: STUDY_CHAIR
Name: Mark Levine, MD
Affiliation: McMaster University, Ontario Clinical Oncology Group
Role: PRINCIPAL_INVESTIGATOR
Name: Jim Julian, MMath
Affiliation: McMaster University, Dept. of Clinical Epidemiology & Biostatistics
Role: PRINCIPAL_INVESTIGATOR
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