Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Florida
-
Jacksonville, Florida, Stany Zjednoczone, 32224
- Mayo Clinic - Jacksonville
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Standard Port
Patients undergo insertion of the conventional vascular access port (C.
R. Bard, Inc., Murray Hill, NJ).
Patients then receive standard chemotherapy.
|
|
|
Eksperymentalny: Vortex Implantable Access Port
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA).
Patients then receive standard chemotherapy.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Port Failure Within 12 Months of Port Insertion
Ramy czasowe: 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.
|
Up to 12 months from port insertion
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Death From All Causes
Ramy czasowe: Up to 12 months after port insertion
|
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
Ramy czasowe: Up to 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.
|
Up to 12 months after port insertion
|
|
Termination of Use of the Indwelling Port at 12 Months After Port Insertion
Ramy czasowe: Up to 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Albert G. Hakaim, MD, Mayo Clinic
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- P30CA015083 (Grant/umowa NIH USA)
- 52-04 (Inny identyfikator: Mayo Clinic Cancer Center & Mayo Clinic IRB)
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