Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
9 de abril de 2014 actualizado por: Mayo Clinic
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
100
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic - Jacksonville
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard Port
Patients undergo insertion of the conventional vascular access port (C.
R. Bard, Inc., Murray Hill, NJ).
Patients then receive standard chemotherapy.
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Port Failure Within 12 Months of Port Insertion
Periodo de tiempo: Up to 12 months from port insertion
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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.
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Up to 12 months from port insertion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Death From All Causes
Periodo de tiempo: Up to 12 months after port insertion
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Number of patients that died during treatment due to any cause.
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Up to 12 months after port insertion
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Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
Periodo de tiempo: Up to 12 months after port insertion
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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.
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Up to 12 months after port insertion
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Termination of Use of the Indwelling Port at 12 Months After Port Insertion
Periodo de tiempo: Up to 12 months after port insertion
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The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.
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Up to 12 months after port insertion
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Albert G. Hakaim, MD, Mayo Clinic
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2004
Finalización primaria (Actual)
1 de marzo de 2009
Finalización del estudio (Actual)
1 de marzo de 2009
Fechas de registro del estudio
Enviado por primera vez
1 de febrero de 2008
Primero enviado que cumplió con los criterios de control de calidad
1 de febrero de 2008
Publicado por primera vez (Estimar)
6 de febrero de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
9 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
9 de abril de 2014
Última verificación
1 de abril de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- P30CA015083 (Subvención/contrato del NIH de EE. UU.)
- 52-04 (Otro identificador: Mayo Clinic Cancer Center & Mayo Clinic IRB)
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