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

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

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 Overview

• Status: Completed
• Conditions: Solid Tumor, Adult; Chemotherapy Treatment; Advanced or Metastasis Stage
• Intervention / Treatment: Device: IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.; Device: Vital Port®Minititanium

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brittany
    • Rennes, Brittany, France, 35000
      • Center Eugene Marquis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard 1 : Thoracic location; The intervention is characterized by the randomization into thoracic arm which means that patients will have an implantable Venous Access Device implanted into thoracic location	Device: IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.; Implantation of intravenous medical device in thoracic location
Other: Standard 2 : Humeral location; The intervention is characterized by the randomization into humeral arm which means that patients will have an implantable Venous Access Device implanted into humeral location	Device: Vital Port®Minititanium; Implantation of intravenous medical device in humeral location

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of complications related to Implantable Venous Access Device	Number of complications that will be recorded by medical oncologist	3 months after medical device placement

Collaborators and Investigators

• Sponsor: Center Eugene Marquis
• Investigators: Principal Investigator: Laurence CROUZET, MD, Centre Eugène Marquis, Rennes, France

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): December 26, 2023
• Study Completion (Actual): September 17, 2024

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: 2016-4-46-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No