Status:

COMPLETED

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

Lead Sponsor:

Center Eugene Marquis

Conditions:

Solid Tumor, Adult

Chemotherapy Treatment

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 9 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 17 2024

Estimated Enrollment :

361 Patients enrolled

Trial Details

Trial ID

NCT03410121

Start Date

March 9 2018

End Date

September 17 2024

Last Update

August 5 2025

Active Locations (1)

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1

Center Eugene Marquis

Rennes, Brittany Region, France, 35000