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

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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Vascular Access Device Complications
• Intervention / Treatment: Procedure: vascular access device placement

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Jacksonville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Port; 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
Experimental: Vortex Implantable Access Port; 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

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Albert G. Hakaim, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 1, 2008
• First Submitted That Met QC Criteria: February 1, 2008
• First Posted (Estimate): February 6, 2008

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: April 9, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; vascular access device complications
• Other Study ID Numbers: P30CA015083 (U.S. NIH Grant/Contract); 52-04 (Other Identifier: Mayo Clinic Cancer Center & Mayo Clinic IRB)