- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01246843
Evaluation of Cognitive Function of Patients With Sunitinib or Sorafenib
Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib
Patients with advanced kidney cancer or GIST (Gastro Intestinal Stromal Tumor: this is a tumor of the intestines) may be eligible for treatment with one of the following drugs: sunitinib (Sutent ®) or sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in cancer cells. These cancer cells are hampered in their growth. To enlarge the investigators knowledge on the effects and side effects of these two medicines, in the University Medical Center St. Radboud lot of research is done. This study is a part of that.
Patients receiving sunitinib or sorafenib tell sometimes that they feel that they are less able to concentrate, that their memory is not working properly or that they are less able to imagine a solution to a complex problem . Perhaps you recognize these symptoms as well. In how many of the patients this occurs, how severe the symptoms are and how it is caused, is still unknown.
The goal of this research is to examine how memory, concentration and knowledge processing works in patients using sorafenib or sunitinib. With the research the investigators hope to get answers to the following questions:
- How common are problems with memory, concentration and processing of knowledge in patients receiving the drug sunitinib or sorafenib?
- What are the problems of memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
- What could be the cause of the problems that patients experience from memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
- Is there a link between problems with memory, concentration and processing of knowledge and also experiences of fatigue or mood of a patient?
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Gelderland
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Nijmegen, Gelderland, Países Bajos, 6500 HB
- University Medical Centre Nijmegen
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients:
- patients with metastatic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for ≥ 8 weeks
- Karnofsky score > 70%
- age > 18 year.
- written informed consent for study
Patient controls selection
- patients with metastatic renal cell cancer or GIST who aren't treated yet (only interferon alfa or interleukine 2 treatment is allowed when > 12 months ago.
- Karnofsky score > 70%
- age > 18 year.
- written informed consent for study
Exclusion Criteria:
- Patients:
- contra-indications for treatment with Sunitinib or Sorafenib
- patients who do not speak or write the Dutch language adequately
- known brain metastasis
- use of psychiatric or anti-epileptic medication
- known cognitive disorders unrelated to diagnosis or medication use
- radiotherapy on the brain at any time in the past
- systemic chemotherapy
- in the last 12 months interferon alfa or interleukin-2 treatment
- operation in the last 3 months
- Stroke/TIA (transient ischaemic attack)
Patient controls section:
- patients who do not speak or write the Dutch language adequately
- known brain metastasis
- use of psychiatric or anti-epileptic medication
- known cognitive disorders unrelated to diagnosis or medication use
- radiotherapy on the brain at any time in the past
- systemic chemotherapy
- in the last 12 months interferon alfa or interleukin-2 treatment
- operation in the last 3 months
- stroke/TIA (transient ischaemic attack)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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metastatic Renal Cell Carcinoma without treatment
patients with metastasized RCC who did not receive treatment
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mRCC with treatment
patients with metastastic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for ≥ 8 weeks |
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UMCNONCO200904
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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