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Spots Global Cancer Trial Database for Extended Peri-operative Tinzaparin to Improve Disease-free Survival in Patients With Resectable Colorectal Cancer

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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