Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy

Center Eugene Marquis361 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

361

Conditions

Solid Tumor, Adult Chemotherapy Treatment Advanced or Metastasis Stage

Interventions

IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.DEVICE

Implantation of intravenous medical device in thoracic location

Vital Port®MinititaniumDEVICE

Implantation of intravenous medical device in humeral location

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Center Eugene Marquis

Rennes, Brittany Region, France

Outcomes

Primary Outcomes

Number of complications related to Implantable Venous Access Device

Number of complications that will be recorded by medical oncologist

Time frame: 3 months after medical device placement

Data from ClinicalTrials.gov

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