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

NCT03410121 | Completed

• 1 other identifier: 2016-4-46-002
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor, Adult; Chemotherapy Treatment; Advanced or Metastasis Stage

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard 1 : Thoracic location

OTHER

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.

Standard 2 : Humeral location

OTHER

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

Interventions

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

Implantation of intravenous medical device in thoracic location

Standard 1 : Thoracic location

Vital Port®Minititanium DEVICE

Implantation of intravenous medical device in humeral location

Standard 2 : Humeral location

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (1)

Center Eugene Marquis

Rennes, Brittany Region, 35000, France

Location

Study Officials

• Laurence CROUZET, MD

  Centre Eugène Marquis, Rennes, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 25, 2018
• Study Start: March 9, 2018
• Primary Completion: December 26, 2023
• Study Completion: September 17, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)