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

Solid Tumor, Adult Clinical Trial

— PACPAC-EPOC  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03410121
• Other study ID #: 2016-4-46-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 361
• Est. completion date: November 30, 2024
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced or Metastasis Stage
• Chemotherapy Treatment
• Neoplasm Metastasis
• Neoplasms
• Solid Tumor, Adult

Intervention

Device:
• IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.
Implantation of intravenous medical device in thoracic location
• Vital Port®Minititanium
Implantation of intravenous medical device in humeral location

Locations

Country	Name	City	State
France	Center Eugene Marquis	Rennes	Brittany

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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