Extended Peri-operative Tinzaparin to Improve Disease-free Survival in Patients With Resectable Colorectal Cancer
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
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.