Overview

Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
The blood thinner "tinzaparin" might increase survival in patients with colon cancer undergoing surgical resection. The investigators want to assess if a trial allocating patients to prolonged treatment with tinzaparin versus standard of care is feasible.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborator:
LEO Pharma
Treatments:
Dalteparin
Heparin, Low-Molecular-Weight
Tinzaparin
Criteria
Inclusion Criteria:

- Males or females aged 18 years or older with a pathologically confirmed localized
invasive colorectal cancer and no evidence of metastatic disease who are scheduled to
undergo surgical resection will be eligible.

- All study patients must be enrolled at least two weeks prior to scheduled surgery and
provide written informed consent.

- All the following criteria must be met to be eligible:

1. Pathological confirmation of an invasive adenocarcinoma of the colon;

2. No evidence of metastatic disease by Computed Tomography (CT) scan of the abdomen
and pelvis or chest X-ray (CXR). A Magnetic Resonance Imaging (MRI) of the
abdomen and pelvis will be used if the patient has a documented contrast allergy
or to verify a questionable finding on the CT scan. Any abnormal findings on CXR
will be investigated with a CT scan of the chest. Imaging must be performed
within 2 months of randomization;

3. a scheduled surgical operation for resection of the colon cancer; and

4. ECOG performance status 0 or 1.

Exclusion Criteria:

- Subjects cannot be included in this study if any of the following criteria apply:

1. rectal adenocarcinoma (defined as tumor below the peritoneal reflection or within
12 cm of the anal verge by rigid sigmoidoscopy);

2. prior VTE including deep vein thrombosis (DVT) or pulmonary embolism (PE);

3. requirement for full dose perioperative anticoagulation;

4. requirement for anti-platelet or anti-inflammatory therapy that cannot be
discontinued;

5. contraindication to heparin therapy **;

6. geographic inaccessibility (less likely to comply with required follow-up visits
and care);

7. participating in another interventional trial that may result in co-intervention
or contamination (to be determined by PI);

8. < 18 years of age;

9. history of other malignancies (except for adequately treated basal or squamous
cell carcinoma or carcinoma in situ) within 5 years of the colorectal cancer
diagnosis;

10. treatment, including radiation therapy, chemotherapy or targeted therapy,
administered for the currently diagnosed colon cancer prior to randomization;

11. pregnant or lactating; and

12. unable/unwilling to providing informed consent.