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

Sponsor

Center Eugene Marquis (Other)

Overall Status

Recruiting

CT.gov ID

NCT03410121

Collaborator

(none)

572

Enrollment

Location

Arms

85.7

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor, Adult Chemotherapy Treatment Advanced or Metastasis Stage	Device: IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. Device: Vital Port®Minititanium	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

572 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Mar 9, 2018

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of complications related to Implantable Venous Access Device [3 months after medical device placement]
Number of complications that will be recorded by medical oncologist

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center Eugene Marquis	Rennes	Brittany	France	35000

Sponsors and Collaborators

Center Eugene Marquis

Investigators

Principal Investigator: Laurence CROUZET, MD, Centre Eugène Marquis, Rennes, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Center Eugene Marquis

ClinicalTrials.gov Identifier:

NCT03410121

Other Study ID Numbers:

2016-4-46-002

First Posted:

Jan 25, 2018

Last Update Posted:

Jul 27, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Neoplasm Metastasis

Study Results

No Results Posted as of Jul 27, 2021