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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| 52-04 | Other Identifier | Mayo Clinic Cancer Center & Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 intervention arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Port | Active Comparator | Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy. |
|
| Vortex Implantable Access Port | Experimental | Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vascular access device placement | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Port Failure Within 12 Months of 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. | Up to 12 months from port insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Death From All Causes | Number of patients that died during treatment due to any cause. | Up to 12 months after port insertion |
| Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion |
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DISEASE CHARACTERISTICS:
Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months
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:
No known active infection requiring antibiotic therapy at the time of port implantation
No concurrent illness requiring chronic anticoagulation
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Albert G. Hakaim, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
One patient in the Standard Access Port group was unable to have the port placed due to chronic left internal jugular occlusion and was excluded from the analyses.
All patients considered for port implantation for intravenous chemotherapy were consulted and evaluated for port implantation. This evaluation was not study specific. If the implantation of a port system was feasible, the patient fulfilled inclusion criteria and the patient consented to the study, then they were randomly assigned a treatment port.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Access Port | Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy. |
| FG001 | Vortex Implantable Access Port | Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All 100 patients accrued to participate in this study were included in the baseline population analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Access Port | Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy. |
| BG001 | Vortex Implantable Access Port |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Port Failure Within 12 Months of 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. | Patients with port failure within 12 months and patients that were followed 12 months without port failure were included in this analysis. | Posted | Number | 95% Confidence Interval | percentage of patients | Up to 12 months from port insertion |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Access Port | Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular - Other | Vascular disorders | MedDRA 10.0 | Systematic Assessment | Vascular Access Complication, Port Occlusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albert G. Hakaim, M.D. | Mayo Clinic | Hakaim.Albert@mayo.edu |
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We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.
| Up to 12 months after port insertion |
| Termination of Use of the Indwelling Port at 12 Months After Port Insertion | The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint. | Up to 12 months after port insertion |
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Vortex Implantable Access Port | Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy. |
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| Secondary | Death From All Causes | Number of patients that died during treatment due to any cause. | Posted | Number | participants | Up to 12 months after port insertion |
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| Secondary | Port Removal for Any Reason Other Than Infection or Occlusion Within 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. | All patients accrued to this study that had their port removed within12 months for any reason other than infection/occlusion were included in this analysis. 28 patients using the Standard Access Port and 30 patients using the Vortex Implantable Access Port had port removal prior to 12 months due to reasons other than infection or occlusion.. | Posted | Number | participants | Up to 12 months after port insertion |
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|
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| Secondary | Termination of Use of the Indwelling Port at 12 Months After Port Insertion | The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint. | Posted | Number | participants | Up to 12 months after port insertion |
|
|
|
| 5 |
| 49 |
| 0 |
| 49 |
| EG001 | Vortex Implantable Access Port | Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy. | 4 | 50 | 0 | 50 |
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| Infection with unknown ANC: Blood | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Skin Erosion |
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| Unhealed Incision |
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| Thrombosis |
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| Patient Moved/Transferred Care |
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| Patient Request |
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| Unknown |
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