- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04203849
Prospective Cohort Study of Breast Cancer Patients Treated With Radiotherapy
Prospective Cohort Study for Identifying Factors Predicting Clinical Outcomes of Breast Cancer Patients Treated With Radiotherapy
breast cancer occurred 19,219cases in 2015 and is the second most common cancer among female cancers in the country. despite there's been a disease understanding and treatment developing through study, the prevalence and mortality of breast cancer have increased steadily over the last 15 years. In the last 20 years, through random clinical studies of breast cancer, radiation therapy is well-established standard therapy as postoperative supplement of invasive breast cancer and intraepithelial carcinoma but, the need for further study with new questions about radiation therapy has been raised through these studies. according to the prospective study outcome, the radiation treatment of the regional lymph node in breast cancer patients with lymph node positive increases the free-disease survival rate, radiation therapy for regional lymph node is being actively treated than in the past. on the contrary, the results of another study are being reported that treating regional lymph node may increase the risk of arm edema, radiation pneumonia and heart toxicity. In the recently, due to advancement in radiation therapy technique, the implement of new radiation therapy such as IMRT that reducing radiation dose to normal tissues of the axillary, lungs, heart and others has been actively attempted.
additional research is needed on dose-fractionation schedule, regional lymph node treatment, post-treatment toxicity of radiation therapy in breast cancer. this study establishes a prospective cohort at breast cancer patients with radiation treatment and analyze the local and regional lymph node control, recurrence, toxicity, radiation planning, clinical data, discover the factors that predict local control, regional control, overall survival, recurrence-free survival, toxicity for treatment, so we intend to construct basic data that establishes a radiation treatment strategy based on comprehensive outcomes and predictors.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Gyeonggi
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Goyang, Gyeonggi, Corea, república de, 410-769
- National Cancer Center Korea
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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:
- scheduled to be a radiotherapy at National cancer center
- agreed to participate in the study
Exclusion Criteria:
- disagreed to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
local and regional lymphnode control, free-recurrence, survival period
Periodo de tiempo: up to 6 month
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local and regional lymphnode control, free-recurrence, survival period is defined as the date of occurrence or end based of an event on the date of breast cancer diagnosis. the date of occurrence of an event means the progress of local and region lymph node by disease, the recurrence(or progression) of disease or the confirmed date of death and the date of disconnection means the final date on which the event was determined not to have occurred.
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up to 6 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
therapeutic responses according to image examination
Periodo de tiempo: up to 6 month
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therapeutic responses according to image examination is calculated as the fraction of the subjects who showed either 'CR' or 'PR' according to the RECIST criteria. *Response Criteria (RECIST)
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up to 6 month
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toxicity of radiotherapy
Periodo de tiempo: up to 6 month
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toxicity is calculated as the fraction of toxicity higher than grade 3 according to CTCAE.
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up to 6 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tae H Kim, Ph.D, National Cancer Center, Korea
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCC2019-0142
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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