Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients (NCT00199602) | Clinical Trial Compass
CompletedPhase 3
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
France420 participantsStarted 1999-08
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy