NCT00199602

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_3 cancer

Timeline
Completed

Started Aug 1999

Longer than P75 for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 24, 2018

Status Verified

December 1, 2008

Enrollment Period

10.3 years

First QC Date

September 14, 2005

Last Update Submit

August 22, 2018

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • - 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

  • +1 more secondary outcomes

Study Arms (3)

lack of drug prophylaxis

NO INTERVENTION

HBPM 2500 UI anti Xa in one subcutaneous injection per day

EXPERIMENTAL
Drug: warfarine - low molecular heparin

warfarine 1mg daily

EXPERIMENTAL
Drug: warfarine - low molecular heparin

Interventions

warfarine - low molecular heparinDRUG
HBPM 2500 UI anti Xa in one subcutaneous injection per daywarfarine 1mg daily

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncologie Médicale

Limoges, 87000, France

Location

Related Publications (1)

  • 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.

    PMID: 23636449RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Nicole TUBIANA-MATHIEU, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

August 1, 1999

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

August 24, 2018

Record last verified: 2008-12

Locations

FR(1)