Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients). Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months

Official Title
-----------------
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: warfarine - low molecular heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First line chemotherapy for solid tumor with: Metastatic disease or Involved nodes or Unresectable tumor Indication for Implantable device for central venous access Potential survival > 3 months ECOG performance status 0 to 2 (WHO) Age between 18 and 75 years. Social security guaranteed Normal laboratory assessments (platelets> 100000/mm3, TP 60%, spontaneous TCA with M/T<1.5, TGO and TGP < 2xN, serum creatinin<120µmol/l) Informed consent signed Exclusion Criteria: Inability to understand informed consent or interfering with compliance for treatment or protocol Anti-coagulant treatment -related criteria Acute infectious endocarditis History related with heparin allergy or thrombopenia due to heparin Uncontrolled high blood pressure (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg) Hemorrhagic syndrome ongoing Patient with platelet inhibitors treatment Chronic, daily treatment with anti-coagulant therapy (LMWH or AVK), use as preventive or curative level Patient with liver failure (TP<60%) or renal insufficiency (creatinin clearance< 20 ml/mn) Women with pregnancy and lactating Pathology-related criteria deep venous thrombosis history or pulmonary embolism (< 6 months) Clinical suspicious of brain metastasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: lack of drug prophylaxis<br> | |
| Experimental: HBPM 2500 UI anti Xa in one subcutaneous injection per day<br> | Drug: warfarine - low molecular heparin<br> <br> |
| Experimental: warfarine 1mg daily<br> | Drug: warfarine - low molecular heparin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis : |  | Day90 | 
| Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy |  | Day90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. - |  | Day90 | 
| - Frequency of other symptomatic venous thromboembolic events between 3 groups. |  | J0, J1, J21, J42, J63 and J90 | 
| Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose |  | Day90 | 
| -Costs in the 3 strategies |  | J90 | 
| - Tumoral response to chemotherapy in the 3 groups. |  | Day90 | 
| - Overall survival in each group. |  | Day90 |