Comparison 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)

Center Eugene Marquis

Status: Completed

Conditions: Advanced or Metastasis Stage; Solid Tumor, Adult; Chemotherapy Treatment

Treatments: Device: Vital Port®Minititanium; Device: IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.

Study type: Interventional

Funder types: Other

Identifiers

NCT03410121

2016-4-46-002

Details and patient eligibility

About

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.

Enrollment: 361 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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361 participants in 2 patient groups

Standard 1 : Thoracic location

Other group

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

Treatment:

Device: IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.

Standard 2 : Humeral location

Other group

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

Treatment:

Device: Vital Port®Minititanium