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Brief Title: Extended Peri-operative Tinzaparin to Improve Disease-free Survival in Patients With Resectable Colorectal Cancer
Official Title: A Multicentre Randomized Controlled Trial of the Use of Extended Peri-Operative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colorectal Cancer
Study ID: NCT01455831
Brief Summary: The human body has a natural stress response to surgery, including the formation of blood clots. This response to surgery has been shown to increase metastases (the spread of cancer cells to other organs in the body). These metastases cannot be seen at the time of surgery but when they grow into new tumors, the cancer has recurred (come back). A blood thinner called "low molecular weight heparin" (LMWH) can suppress the development of metastases after surgery in animal experiments. The investigators want to see if giving patients with colorectal cancer the blood thinner, LMWH, around the time of surgery can decrease the chance of their cancer spreading to other organs (metastases) and coming back (recurrence). The investigators need 1075 patients to answer our scientific question. Patients who give informed consent will be randomly put into one of two groups, the experimental group and the control group. The patients in the control group will be treated with LMWH starting a few hours after surgery and every day until they leave the hospital. This is how most patients are treated after colon cancer surgery (standard care). The patients in the experimental group will be treated with LMWH for a longer period of time, starting on the day they agree to have surgery and continuing for two months after surgery. All the patients will be followed for at least three years after surgery to find out if their cancer has recurred (come back). If LMWH treatment around the time of surgery reduces the chance of recurrence in patients with colorectal cancer, it would improve the health and quality of life for these patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ghent University Hospital, Ghent, , Belgium
Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada
Kingston General Hospital, Kingston, Ontario, Canada
London Health Research Institute, London, Ontario, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Montfort Hospital, Ottawa, Ontario, Canada
Queensway Carleton Hospital, Ottawa, Ontario, Canada
Sault Area Hospital, Sault Ste. Marie, Ontario, Canada
Health Sciences North, Sudbury, Ontario, Canada
Humber River Hospital, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
North York General Hospital, Toronto, Ontario, Canada
St. Joseph's Health Centre, Toronto, Ontario, Canada
Sunnybrook Health Science Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CHRU Brest, Brest, , France
Name: Marc Carrier, MD
Affiliation: Ottawa Hospital Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Rebecca Ann Auer, MD
Affiliation: Ottawa Hospital Research Institute
Role: PRINCIPAL_INVESTIGATOR