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- Ensayo clínico NCT01339832
An Observational Study of Xeloda (Capecitabine) and Oxaliplatin Prior and Concurrent To Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer
12 de abril de 2017 actualizado por: Hoffmann-La Roche
Capecitabine and Oxaliplatin Prior and Concurrent to Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer: A Survival Analysis.
This observational study is a follow-up study of protocol ML18280.
Survival data of patients who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV of ML18270.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
51
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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Basel, Suiza, 4031
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Chur, Suiza, 7000
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Luzern, Suiza, 6004
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St. Gallen, Suiza, 9007
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Zürich, Suiza, 8063
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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
Método de muestreo
Muestra no probabilística
Población de estudio
Colorectal cancer patients having taken part in study ML18280
Descripción
Inclusion Criteria:
- Patients who took part in and concluded study ML18280 according to protocol
Exclusion Criteria:
- N/A
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
Cohortes e Intervenciones
Grupo / Cohorte |
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Grupo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression-free Survival
Periodo de tiempo: Up to 5 years
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Progression free survival (PFS) was measured from the date of first administration of study medication in ML18280 study to the date of progression or death, whatever the cause.
In participants with measurable disease, progression was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0.
Participants with neither tumor recurrence nor death were censored at the last tumor assessment date they were known to have not progressed (last date of diagnostic procedure or diagnostic marker reported in the surveillance).
PFS time in days was calculated as PFS [days]= date of tumor recurrence/death date of first intake + 1, if participant had tumor recurrence confirmed by diagnostic imaging or participant died, then PFS [days] =last diagnostic procedure/marker date- date of first intake+ 1, and if participant survived without tumor recurrence PFS time in months was calculated as PFS [months]= 12 * PFS [days] /365.25
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Up to 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall Survival
Periodo de tiempo: Up to 5 years
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Overall survival (OS) was defined as time from date of first administration of the study medication in ML18280 study to date of death from any cause.
Participants without documented date of death were assumed to be alive and were censored at the latest of the following dates: last date alive on survival status pages, last date known to be alive on survival status pages, and last date of tumor assessment (diagnostic procedures or markers) on surveillance pages.
OS time in days was calculated as OS [days] =date of death date of first intake+ 1, for participants who died, OS [days]= censoring date date of first intake+ 1, for participants alive, and OS time in months was calculated as OS [months]= 12 *OS [days] /365.25
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Up to 5 years
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Tumor Recurrence Rate (Local and Distant)
Periodo de tiempo: Up to 5 years
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Participant with tumor recurrence were determined by the presence or absence of date of tumor recurrence detection.
In case of absence of empty tumor recurrence date it was considered that the participant had not experienced tumor recurrence.
Participants with local tumor recurrence ('Was it local to the primary tumor?' answered 'yes'.)
compared to participants with distant tumor recurrence (specification for other tumor location given).
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Up to 5 years
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Type of Adjuvant Chemotherapy
Periodo de tiempo: Up to 5 years
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The type of therapies administered after primary treatments (chemotherapy, surgery or radiation) was reported
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Up to 5 years
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Length of Adjuvant Chemotherapy
Periodo de tiempo: Up to 5 years
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The length of adjuvant chemotherapy was defined as time between first start date to last stop date of adjuvant chemotherapy regimen.
Length of adjuvant chemotherapy was calculated as length [days] = last stop date - first start date + 1, missing day of start and stop date was replaced by 1.
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Up to 5 years
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Compliance to Diagnostic Procedures in Surveillance
Periodo de tiempo: Up to 5 years
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The surveillance compliance was calculated per participant in percent and frequencies for methods of diagnostic procedure adhered to, taking into account all expected procedures in the time span the participant participated and was based on the Swiss Society of Gastroenterology (SGG) follow-up care recommendations
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Up to 5 years
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Long Term Side Effects
Periodo de tiempo: Up to 5 years
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Long term side effects for bowel and urinary function was assessed.
Bowel function was assessed in terms of mean bowel frequency, regular use of constipating agents as well as fecal incontinence.
Urinary function was evaluated according to the presence (YES or NO) of incontinence.
Overall participant satisfaction was assessed in terms of satisfaction with bowel, stoma and urinary function on a 4-stage scale (very good, good, poor, and very poor).
In case of different assessment(s) of bowel or urinary function within the same surveillance period, the assessment with worst grade was documented and reported.
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Up to 5 years
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Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)
Periodo de tiempo: Up to 5 years
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An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes
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Up to 5 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 agosto de 2010
Finalización primaria (Actual)
1 de diciembre de 2011
Finalización del estudio (Actual)
1 de diciembre de 2011
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2011
Primero enviado que cumplió con los criterios de control de calidad
20 de abril de 2011
Publicado por primera vez (Estimar)
21 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
12 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ML21875
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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