A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer
15 de marzo de 2018 actualizado por: Hoffmann-La Roche
Retrospective Multicenter Observational Study to Evaluate Safety and Effectiveness of Bevacizumab (Avastin®) in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Patients With Advanced Cervical Cancer
This study will evaluate the safety of bevacizumab (Avastin®) combined with standard chemotherapy in participant with advanced cervical cancer, with special focus on the incidence of gastrointestinal (GI) and genitourinary (GU) fistulas and GI perforations in the common practice setting.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
84
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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Buenos Aires, Argentina, 1437
- Hospital General de Agudos J. A. Penna ; Breast Pathology
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Buenos Aires, Argentina, B1650
- Instituto Ángel H. Roffo - Universidad de Buenos Aires
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Chaco, Argentina
- Hospital Julio C. Perrando
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Ciudad Autonoma de Buenos Aires, Argentina, 1425
- Hospital General de Agudos Juan Antonio Fernandez
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Jujuy, Argentina
- Hospital Pablo Soria
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La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral (Cori)
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Lomas de Zamora, Argentina
- Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
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Mar Del Plata, Argentina, 7600
- Hospital Privado de Comunidad; Oncology
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Rosario, Argentina, S2002KDS
- Hosp Provincial D. Centenarios; Oncology Dept
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Rosario, Argentina
- CENICLAR
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San Luis, Argentina
- Policlínico regional de San Luis
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San Miguel de Tucuman, Argentina, T4000IAK
- Centro Medico San Roque
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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
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
Participants with advanced cervical cancer (metastatic, recurrent or persistent) who have received treatment with bevacizumab from 01 January 2015 to 01 January 2016 will be observed.
Descripción
Inclusion Criteria:
- Age 18 or older
- Diagnosis of primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
- Retrospective clinical decision made to initiate therapy with bevacizumab (Avastin®) combined with standard chemotherapy (cisplatin or carboplatin or topotecan and paclitaxel) between 01 January 2015 and 01 January 2016
- All participants must have received at least one dose of bevacizumab combined with standard chemotherapy between 01 January 2015 and 01 January 2016 AND have at least 12 months of documented follow up, from treatment start, unless died or lost to follow up within the minimum study entry follow up period
- Availability of documentation of for advanced cervical cancer (including prior treatment as applicable) and follow up in the participant's medical records
Exclusion Criteria:
- Participation during the study period in an interventional clinical trial or any other interventional study that may impact advanced cervical cancer outcome
- Participants who have received prior therapy with any anti-VEGF drug, including bevacizumab
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 |
Intervención / Tratamiento |
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Bevacizumab
Participants with advanced cervical cancer (metastatic, recurrent or persistent) who have received treatment with bevacizumab from 01 January 2015 to 01 January 2016 (retrospective and independent from this study) combined with standard chemotherapy (cisplatin/carboplatin or topotecan and paclitaxel) will be observed.
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This was an observational study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
Periodo de tiempo: Up to 12 months
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Participants with GI and GU fistulas and GI perforation events will be reported according to Common Terminology Criteria for Adverse Events (CTCAE V4.0).
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Up to 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events
Periodo de tiempo: Up to 12 months
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Participants who received radiotherapy prior to GI and GU fistulas and GI perforation events will be reported.
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Up to 12 months
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Percentage of Participants who Received Internal, External and Other Radiotherapy
Periodo de tiempo: Up to 12 months
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Participants who received internal, external and other radiotherapy will be reported.
External radiotherapy will include "Non Precision Orientated" that includes classic cobalt or "Precision Orientated" that includes Linear accelerator.
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Up to 12 months
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Number of Doses of Prior Radiotherapy
Periodo de tiempo: Up to 12 months
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Doses of prior radiotherapy will be reported.
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Up to 12 months
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Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)
Periodo de tiempo: Up to 12 months
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Adverse events of special interest (AESI) for this study included: hypertension, proteinuria, wound healing complication, bleeding /haemorrrhage (including pulmonary haemorrhage and CNS bleeding), arterial and venous thromboembolic events (ATES; VTES), congestive heart failure (CHF), posterior reversible encephalopathy syndrome (PRES), fistula/abscess (other than genitourinary and gastrointestinal), gastrointestinal perforations and gallbladder perforation.
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Up to 12 months
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Overall Response Rate (ORR)
Periodo de tiempo: Up to 12 months
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Overall response rate was defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR).
CR is defined as disappearance of all target and non-target lesions.
PR is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
There can be no unequivocal progression of non-target lesions and no new lesions.
In the case where the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
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Up to 12 months
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Progression Free Survival (PFS)
Periodo de tiempo: Up to 12 months
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PFS is defined as the time from the first dose of treatment to the first occurrence of progression, or death from any cause as assessed by the investigator.
Progressive disease (PD): at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry.
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Up to 12 months
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Overall Survival (OS)
Periodo de tiempo: Up to 12 months
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OS is defined as the time from the first dose of treatment to death from any cause.
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Up to 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
6 de abril de 2017
Finalización primaria (Actual)
20 de diciembre de 2017
Finalización del estudio (Actual)
20 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
2 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
2 de marzo de 2017
Publicado por primera vez (Actual)
7 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
15 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ML39360
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. .