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CompletedNCT03410121PACPAC-EPOCUpdated Aug 5, 2025

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

An interventional study of IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. and Vital Port®Minititanium in Solid Tumor, Adult, Chemotherapy Treatment and Advanced or Metastasis Stage, sponsored by Center Eugene Marquis. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Center Eugene Marquis · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
361
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumor, Adult
  • Chemotherapy Treatment
  • Advanced or Metastasis Stage
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
361 participants (actual)

Study arms

  • 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.

  • 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

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

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 site
  • Center Eugene Marquis
    Rennes, Brittany Region 35000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03410121
Lead sponsor
Center Eugene Marquis
Responsible party
Sponsor
First posted
Jan 25, 2018
Start date
Mar 9, 2018
Primary completion
Dec 26, 2023
Completion
Sep 17, 2024
Last update
Aug 5, 2025

Study contacts

Laurence CROUZET, MD
principal investigator · Centre Eugène Marquis, Rennes, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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