Clinical trial NCT00199602: Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Official title: Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: 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 :
timeFrame: Day90
measure: Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
timeFrame: Day90
Secondary outcomes:
measure: - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -
timeFrame: Day90
measure: - Frequency of other symptomatic venous thromboembolic events between 3 groups.
timeFrame: J0, J1, J21, J42, J63 and J90
measure: Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose
timeFrame: Day90
measure: -Costs in the 3 strategies
timeFrame: J90
measure: - Tumoral response to chemotherapy in the 3 groups.
timeFrame: Day90
measure: - Overall survival in each group.
timeFrame: Day90
Other outcomes:
Locations:
city: Limoges
country: France
facility: Oncologie Médicale
Study officials:
affiliation: University Hospital, Limoges
name: Nicole TUBIANA-MATHIEU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavau-Denes S, Lacroix P, Maubon A, Preux PM, Genet D, Venat-Bouvet L, Labourey JL, Martin J, Slaouti P, Tubiana-Mathieu N. Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study. Cancer Chemother Pharmacol. 2013 Jul;72(1):65-73. doi: 10.1007/s00280-013-2169-y. Epub 2013 May 1.