Advanced or Metastasis Stage, Chemotherapy Treatment, Solid Tumor, Adult
Conditions
Brief summary
The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed. Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible. Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.
Interventions
DEVICEIPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.
Implantation of intravenous medical device in thoracic location
DEVICEVital Port®Minititanium
Implantation of intravenous medical device in humeral location
Sponsors
Center Eugene Marquis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with solid tumors at an Advanced or metastasis stage requiring placement of implantable catheter for intravenous chemotherapy treatment * Older than 18 years * Express signed consent
Exclusion criteria
* Life expectancy less than 12 months assessed by investigator * Infection or uncontrolled suspected infection * Medical contraindication to port implantation by catheter in thoracic or humeral location * Pregnant or lactating women * Abnormal coagulation * Immunosuppressed patients (for example known hepatitis B or C, or known positive Human Immunodeficiency Virus due to the spreading risk) * Patient not affiliated to the French social security * Access time to the humeral or thoracic port placement higher than 15 days (from the randomization theoretical date) * Protected Adult or adult deprived of liberty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of complications related to Implantable Venous Access Device | 3 months after medical device placement | Number of complications that will be recorded by medical oncologist |
Countries
France
Outcome results
None listed