Cancer
Conditions
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
Interventions
DRUGwarfarine - low molecular heparin
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose | Day90 |
| -Costs in the 3 strategies | J90 |
| - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. - | Day90 |
| - Overall survival in each group. | Day90 |
| - Tumoral response to chemotherapy in the 3 groups. | Day90 |
| - Frequency of other symptomatic venous thromboembolic events between 3 groups. | J0, J1, J21, J42, J63 and J90 |
Countries
France
Outcome results
None listed