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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199602
• Other study ID #: I99006
• Status: Completed
• Phase: Phase 3
• Start date: August 1999
• Est. completion date: December 2010

Study information

• Verified date: December 2008
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Thrombosis

Intervention

Drug:
• warfarine - low molecular heparin

Locations

Country	Name	City	State
France	Oncologie Médicale	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

References & Publications (1)

Lavau-Denes S, Lacroix P, Maubon A, Preux PM, Genet D, Vénat-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 co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy		Day90
Secondary	- Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -		Day90
Secondary	- Frequency of other symptomatic venous thromboembolic events between 3 groups.		J0, J1, J21, J42, J63 and J90
Secondary	Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose		Day90
Secondary	-Costs in the 3 strategies		J90
Secondary	- Tumoral response to chemotherapy in the 3 groups.		Day90
Secondary	- Overall survival in each group.		Day90