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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607880
• Other study ID #: P30CA015083
• Secondary ID: P30CA01508352-04
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2008
• Last updated: April 9, 2014
• Start date: June 2004
• Est. completion date: March 2009

Study information

• Verified date: April 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific
• Vascular Access Device Complications

Intervention

Procedure:
• vascular access device placement

Locations

Country	Name	City	State
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Death From All Causes	Number of patients that died during treatment due to any cause.	Up to 12 months after port insertion	Yes
Secondary	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	Yes
Secondary	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	Yes