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


Phase 2
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific, Vascular Access Device Complications

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Trial Information

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


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 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Albert G. Hakaim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000581354

NCT ID:

NCT00607880

Start Date:

June 2004

Completion Date:

March 2009

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Vascular Access Device Complications
  • vascular access device complications
  • unspecified adult solid tumor, protocol specific

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224