Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Health services research, Supportive care, Treatment	Active	18 and over	NCI	MAYO-5204 52-04, NCT00607880

Objectives

Primary

1. 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

1. To compare the rate of port malfunction or port infection at 6 and 12 months after port insertion.
2. To compare the rate of central vein thrombosis at 6 and 12 months after port insertion.
3. To compare the rate of port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion.
4. To compare the rate of termination of use of the indwelling port at 6 and 12 months after port insertion.
5. To compare the death from all causes.
6. To compare the incidence of port-related interventions at 6 and 12 months after port insertion.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics

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

Expected Enrollment

Outcomes

Port malfunction due to partial or total occlusion at 6 and 12 months after port insertion
Port infection at 6 and 12 months after port insertion

Central vein thrombosis at 6 and 12 months after port insertion
Death from all causes
Port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion
Termination of use of the indwelling port at 6 and 12 months after port insertion
Calculation of direct costs of treatment for port-occlusions and port-infections at 6 and 12 months after port insertion

Outline

Patients are randomized to 1 of 2 intervention arms.

• Arm I: Patients undergo insertion of the Vortex® implantable vascular access port. Patients then receive standard chemotherapy.



• Arm II : Patients undergo insertion of a conventional 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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Albert Hakaim, MD, Principal investigator		Ph: 507-538-7623

U.S.A.
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623

Registry Information
Official Title		A Prospective Randomized Study of the Vortex® Implantable Access Port versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy
Trial Start Date		2004-06-11
Trial Completion Date		2008-01-31 (estimated)
Registered in ClinicalTrials.gov		NCT00607880
Date Submitted to PDQ		2007-12-12
Information Last Verified		2008-12-28
NCI Grant/Contract Number		CA15083

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