Status:
COMPLETED
Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Vascular Access Device Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 infe...
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 lo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00607880
Start Date
June 1 2004
End Date
March 1 2009
Last Update
May 9 2014
Active Locations (1)
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1
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224