Back to resultsComparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy (PACPAC-EPOC)
Primary Purpose
Solid Tumor, Adult, Chemotherapy Treatment, Advanced or Metastasis Stage
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.
Vital Port®Minititanium
Sponsored by
About this trial
This is an interventional other trial for Solid Tumor, Adult
Eligibility Criteria
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
Sites / Locations
- Center Eugene MarquisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Standard 1 : Thoracic location
Standard 2 : Humeral location
Arm Description
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
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
Outcomes
Primary Outcome Measures
Number of complications related to Implantable Venous Access Device
Number of complications that will be recorded by medical oncologist
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03410121
Brief Title
Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Adult, Chemotherapy Treatment, Advanced or Metastasis Stage
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
572 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard 1 : Thoracic location
Arm Type
Other
Arm Description
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
Arm Title
Standard 2 : Humeral location
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.
Intervention Description
Implantation of intravenous medical device in thoracic location
Intervention Type
Device
Intervention Name(s)
Vital Port®Minititanium
Intervention Description
Implantation of intravenous medical device in humeral location
Primary Outcome Measure Information:
Title
Number of complications related to Implantable Venous Access Device
Description
Number of complications that will be recorded by medical oncologist
Time Frame
3 months after medical device placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence CROUZET, MD
Phone
+ 33 2 99 25 30 00
Email
l.crouzet@rennes.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence CROUZET, MD
Phone
+ 33 2 99 25 30 00
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence CROUZET, MD
Organizational Affiliation
Centre Eugène Marquis, Rennes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center Eugene Marquis
City
Rennes
State/Province
Brittany
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence CROUZET, MD
Phone
+33 299 25 30 00
Email
l.crouzet@rennes.fnclcc.fr
First Name & Middle Initial & Last Name & Degree
Martine GESTIN, PhD
Phone
+33 299 25 30 36
Email
m.gestin@rennes.fnclcc.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy
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