Unspecified Adult Solid Tumor, Protocol SpecificPhase 2NCT00607880
Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
A Phase 2 study testing vascular access device placement in people with Unspecified Adult Solid Tumor, Protocol Specific and Vascular Access Device Complications, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific, Vascular Access Device Complications
- What is being tested?
- vascular access device placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
About this study
Official title: A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy
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.
Read the 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 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 a conventional vascular access port. Patients then receive standard chemotherapy.
- Arm II : Patients undergo insertion of the Vortex® implantable 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.
- Being tested
- vascular access device placement
- Keywords
- vascular access device complications, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular access device placementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: vascular access device placement |
| 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. Receives: Procedure: vascular access device placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months from port insertion
Secondary outcomes (3)
Death From All Causes
Number of patients that died during treatment due to any cause.
Measured: Up to 12 months after port insertion
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.
Measured: 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.
Measured: Up to 12 months after port insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJun 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Albert G. Hakaim, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607880
- Sponsor's protocol ID
- P30CA015083
- Other IDs
- P30CA015083, 52-04
- Status last verified
- Apr 2014
- First submitted
- 1 Feb 2008
- Last updated
- 9 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy
- ClinicalTrials.gov ID
- NCT00607880
- Acronym / sponsor ID
- P30CA015083
- Keywords
- vascular access device complications, unspecified adult solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 9 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 a conventional vascular access port. Patients then receive standard chemotherapy.
- Arm II : Patients undergo insertion of the Vortex® implantable 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Port | Active comparator | Procedure: vascular access device placementPatients 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 | Procedure: vascular access device placementPatients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vascular access device placement | Procedure or surgery | Standard Port, Vortex Implantable Access Port |
Primary outcome
Port Failure Within 12 Months of Port Insertion
Time frame: Up to 12 months from 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.
3 secondary outcomes
Death From All Causes
Time frame: Up to 12 months after port insertion
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Time frame: Up to 12 months after port insertion
Termination of Use of the Indwelling Port at 12 Months After Port Insertion
Time frame: Up to 12 months after port insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
Assessment Tool for Older Patients With Cancer
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
Recruiting
Copenhagen Prospective Personalized Oncology (CoPPO)
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert G. Hakaim, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vascular access device placement in people with Unspecified Adult Solid Tumor, Protocol Specific and Vascular Access Device Complications, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Port Failure Within 12 Months of Port Insertion (time frame: Up to 12 months from port insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.