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

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.

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Key information

Conditions

Solid Tumor, Adult Advanced or Metastasis Stage Chemotherapy Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center Eugene Marquis

Rennes, Brittany Region, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Implantation of intravenous medical device in thoracic location

Vital Port®Minititanium

Device

Implantation of intravenous medical device in humeral location

Primary outcomes

Number of complications related to Implantable Venous Access Device

Time frame: 3 months after medical device placement

Number of complications that will be recorded by medical oncologist

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

Phase IV Study Comparing Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Intravenous Chemotherapy

Acronym: PACPAC-EPOC

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2024
First posted: Jan 25, 2018
Registry last updated: Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed