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Thromboprophylaxis for Patients Undergoing Surgical Resection of Colon Cancer Resection (PERI-OP)

This study has been completed.
Sponsor:
Collaborator:
LEO Pharma
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00967148
First received: July 8, 2009
Last updated: May 11, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Deep Vein Thrombosis
Pulmonary Embolism
Cancer
 Drug: Tinzaparin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of Extended Perioperative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colon Cancer: A Pilot Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Recruitment rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Refusal rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Rate of non-compliance and lost to follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Expression of sialylated fucosylated glycans (including CA19-9, sialyl Lewis X and CD24) in primary tumor specimens by immunohistochemistry (IHC). [ Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4 ] [ Designated as safety issue: No ]
  • Expression of TF. VEGF and microvessel density in primary tumor specimens by IHC. [ Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4 ] [ Designated as safety issue: No ]
  • Serum soluble TF and TFPI levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by enzyme linked immunosorbent assay (ELISA). [ Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4 ] [ Designated as safety issue: No ]
  • Platelet count and serum soluble P-selectin levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by hemocytometer and ELISA. [ Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4 ] [ Designated as safety issue: No ]
  • Serum VEGF levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by ELISA [ Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4 ] [ Designated as safety issue: No ]
  • Quantification and characterization of VPC pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by VPC cell culture assay and flow cytometry. [ Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tinzaparin
The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection.
 Drug: Tinzaparin
The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection.
Other Name: Innohep
Active Comparator: Standard of care
The control arm will receive a subcutaneous injection of 4,500 U of tinzaparin daily beginning with the first postoperative dose and continued for the duration of hospitalization.
 Drug: Tinzaparin
The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection.
Other Name: Innohep

Detailed Description:

Cancer patients are at high risk of postoperative thrombosis and this risk remains elevated beyond the period of hospitalization. Thromboprophylaxis effectively reduces the risk of post operative VTE in cancer patients. Extended thromboprophylaxis beyond hospitalization (up to 30 days) with LMWH has been shown to further reduce the risk of postoperative VTE. Concurrently, there is a growing body of evidence to suggest that LMWH may have anti-cancer effects due to anti-metastatic properties and may improve survival in cancer patients, even in the absence of a documented VTE. Retrospective studies have shown that perioperative thromboprophylaxis (i.e., starting thromboprophylaxis before the surgery) seems to increase survival in cancer patients undergoing abdominal or pelvic cancer surgery with curative intent. The investigators propose to perform an open-label RCT to determine if thromboprophylaxis using tinzaparin 4,500 IU daily, starting from the time of decision to operate through the peri-operative period and extending for 4 weeks postoperatively, is feasible.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967148

Locations
Canada, Ontario
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
LEO Pharma
Investigators
Principal Investigator: Marc Carrier, MD MSc Ottawa Hospital Research Institute
Principal Investigator: Rebecca Auer, MD MSc Ottawa Hospital Research Institute
Study Chair: Tim Asmis, MD Ottawa Hospital
  More Information

No publications provided

Responsible Party: Marc Carrier, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00967148     History of Changes
Other Study ID Numbers: 2009121-01H
Study First Received: July 8, 2009
Last Updated: May 11, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Colonic Neoplasms
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013