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

Phase 2

Completed

• Conditions: Vascular Access Device Complications; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Procedure: vascular access device placement

• Registration Number: NCT00607880
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-06
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2014-04
• Results First Submitted: 2014-04-09
• Results First Submitted QC: 2014-04-09
• Last Update Submitted: 2014-04-09
• Results First Posted: 2014-05-09
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vortex Implantable Access Port	vascular access device placement	Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
Standard Port	vascular access device placement	Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.

Primary Outcome Measures

Name	Time	Method
Port Failure Within 12 Months of Port Insertion	Up to 12 months from 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.

Secondary Outcome Measures

Name	Time	Method
Death From All Causes	Up to 12 months after port insertion	Number of patients that died during treatment due to any cause.
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion	Up to 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.
Termination of Use of the Indwelling Port at 12 Months After Port Insertion	Up to 12 months after port insertion	The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.

Trial Locations

Locations (1)

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States