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

Primary Purpose

Deep Vein Thrombosis, Pulmonary Embolism, Cancer

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Tinzaparin

About this trial

This is an interventional prevention trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ottawa Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tinzaparin

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment rate

Secondary Outcome Measures

Refusal rate

Rate of non-compliance and lost to follow-up

Expression of sialylated fucosylated glycans (including CA19-9, sialyl Lewis X and CD24) in primary tumor specimens by immunohistochemistry (IHC).

Expression of TF. VEGF and microvessel density in primary tumor specimens by IHC.

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).

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.

Serum VEGF levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by ELISA

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.

Full Information

NCT ID

NCT00967148

First Posted

July 8, 2009

Last Updated

October 21, 2014

Sponsor

Ottawa Hospital Research Institute

Collaborators

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00967148

Brief Title

Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer

Acronym

PERI-OP

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

Collaborators

LEO Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Vein Thrombosis, Pulmonary Embolism, Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tinzaparin

Arm Type

Experimental

Arm Description

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Tinzaparin

Other Intervention Name(s)

Innohep

Intervention Description

Primary Outcome Measure Information:

Title

Recruitment rate

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Refusal rate

Time Frame

3 months

Title

Rate of non-compliance and lost to follow-up

Time Frame

6 months

Title

Expression of sialylated fucosylated glycans (including CA19-9, sialyl Lewis X and CD24) in primary tumor specimens by immunohistochemistry (IHC).

Time Frame