Phase 2
N=100
Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
Unspecified Adult Solid Tumor, Protocol Specific · Vascular Access Device Complications
Bottom Line
View on ClinicalTrials.gov: NCT00607880 ↗Enrolled (actual)
100
Serious AEs
9.1%
Results posted
May 2014
Primary outcome: Primary: Port Failure Within 12 Months of Port Insertion — 16.1; 13.8 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- vascular access device placement (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Port Failure Within 12 Months of Port Insertion |
16.1; 13.8 | — |
| SECONDARY Death From All Causes |
9; 6 | — |
| SECONDARY Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion |
9; 6; 7; 6; 1; 0 | — |
| SECONDARY Termination of Use of the Indwelling Port at 12 Months After Port Insertion |
31; 31 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00607880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.