Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple needle sticks. It is not yet known whether one type of port is more effective than another in reducing infections and other side effects associated with long-term port use. PURPOSE: This randomized clinical trial is comparing two types of ports in patients with cancer receiving intravenous chemotherapy.

Detailed Description
-----------------
OBJECTIVES: Primary To compare the rate of port failure, defined as the occurrence of port malfunction or port infection within 12 months after port insertion, in patients with cancer requiring long-term adjuvant intravenous chemotherapy undergoing insertion of a newly designed, FDA-approved Vortex® implantable vascular access port vs a conventional vascular access port. Secondary To compare the rate of port malfunction or port infection at 6 and 12 months after port insertion. To compare the rate of central vein thrombosis at 6 and 12 months after port insertion. To compare the rate of port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion. To compare the rate of termination of use of the indwelling port at 6 and 12 months after port insertion. To compare the death from all causes. To compare the incidence of port-related interventions at 6 and 12 months after port insertion. OUTLINE: Patients are randomized to 1 of 2 intervention arms. Arm I: Patients undergo insertion of a conventional vascular access port. Patients then receive standard chemotherapy. Arm II : Patients undergo insertion of the Vortex® implantable vascular access port. Patients then receive standard chemotherapy. All episodes of access to the port are documented for 12 months after port insertion. Information including the reason for port access and difficulty in access is collected. Complications, such as occlusion and infection, implant duration, and incidence of port-related interventions are assessed at 6 and 12 months after port insertion.

Official Title
-----------------
A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific, Vascular Access Device Complications

Intervention / Treatment
-----------------
* Procedure: vascular access device placement


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months Must undergo entire course of chemotherapy at the Mayo Clinic in Jacksonville, unless the outside treating institution agrees to submit the research data sheet to Mayo Clinic Scheduled time frame for regular use of the vascular access port ≥ 3 months after port insertion PATIENT CHARACTERISTICS: Life expectancy ≥ 6 months No active skin condition implicating an elevated risk of local or systemic infectious or non-infectious complications, including any of the following: Current skin infection Cutaneous lymphoma Auto-immune disorders Active vasculitis Connective tissue diseases No known active infection requiring antibiotic therapy at the time of port implantation Patients without an active infection who are on chronic antibiotic suppressive therapy are eligible No concurrent illness requiring chronic anticoagulation Patients who develop other comorbidities requiring chronic anticoagulation during the study period are eligible PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Port<br>Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy. | Procedure: vascular access device placement<br> <br> |
| Experimental: Vortex Implantable Access Port<br>Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy. | Procedure: vascular access device placement<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Port Failure Within 12 Months of Port Insertion | We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure. | Up to 12 months from port insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death From All Causes | Number of patients that died during treatment due to any cause. | Up to 12 months after port insertion | 
| Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months. | Up to 12 months after port insertion | 
| Termination of Use of the Indwelling Port at 12 Months After Port Insertion | The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint. | Up to 12 months after port insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vascular access device complications, unspecified adult solid tumor, protocol specific