A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)
3 de noviembre de 2015 actualizado por: AstraZeneca
A Retrospective, Non-interventional Study to Evaluate EGFR-Tyrosine Kinase Inhibitor Retreatment in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC Who Previously Treated With EGFR-TKI as First-line Therapy and Chemotherapy as Second-line Therapy - SEQUENCE Study
This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.
Descripción general del estudio
Estado
Terminado
Descripción detallada
This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC.
Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI.
After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified.
The target population will be derived from multicentre in Taiwan.
The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.
Tipo de estudio
De observación
Inscripción (Anticipado)
200
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
-
-
-
Chiayi, Taiwán
-
Kaohsiung, Taiwán
-
Taichung, Taiwán
-
Taipei, Taiwán
-
Taipei, Taiwán
- Research Site
-
Tao Yuan, Taiwán
-
-
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
20 años a 150 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with locally advanced or metastatic Epidermal Growth Factor Receptor mutated Non-small-cell Lung Cancer who Previously Treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First-line therapy and chemotherapy as second-line Therapy - SEQUENCE study
Descripción
Inclusion Criteria:
- Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
- Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
- Female or male aged ≧20 years
- Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:
1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
Periodo de tiempo: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
The median duration of re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor will be summarized by days or months, if applicable.
The range of this treatment duration will also be presented.
All analyses will be performed on all eligible patients in this study.
|
From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Periodo de tiempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
The outcome of progression-free survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve.
PFS is defined as the time interval (in weeks) from the start date of a given treatment to the date of disease progression or death, respectively, which one is observed first.
Subjects who did not progress or die without a reported progression will be censored on the date of their last tumor assessment.
|
From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
|
Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Periodo de tiempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
The outcome of overall survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve.
OS is defined as the time interval (in weeks) from the beginning of treatment until the date when death or lost to follow up is observed.
For those subjects who have not died or lost to follow-up, survival duration will be censored at the last date the subject was known to be alive.
|
From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
|
Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Periodo de tiempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
The outcome about response rate and the proportion of response rate are estimated by all evaluable patients.
The 95% exact confidence interval will be constructed around the rates.
The best response during treatment sequences is determined in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
|
From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
|
Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Periodo de tiempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
The outcome of disease control rate are estimated by all evaluable patients.
The 95% exact confidence interval will be constructed around the rates.
Disease Control Rate is defined as patients who are respond to treatment (including CR-complete respond, PR-partial respond or SD- Stable Disease).
|
From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
|
Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.
Periodo de tiempo: Between the initial EGFR-TKI therapy and first time chemotherapy.
|
Treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.
|
Between the initial EGFR-TKI therapy and first time chemotherapy.
|
|
Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).
Periodo de tiempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).
|
From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
|
|
Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics.
Periodo de tiempo: EGFR-TKI initial and re-administration
|
Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics (including demographics, histology, disease stage, sites of metastasis, ECOG PS) or EGFR TKI treatment characteristics (including EGFR mutation pattern, response to initial EGFR TKI or not, length of duration between first and second EGFR-TKI treatment)
|
EGFR-TKI initial and re-administration
|
|
overall survival (OS), plasma CEA level and chemotherapy regimens ever used.
Periodo de tiempo: between first time chemotherapy and EGFR-TKI re-administration
|
Explore overall survival (OS), plasma CEA level and chemotherapy regimens ever used between first time chemotherapy and EGFR-TKI re-administration (including the types and number of chemotherapy regimens, and treatment duration) for those patients who have the above data available.
|
between first time chemotherapy and EGFR-TKI re-administration
|
|
image peer review to evaluate tumour size retrospectively in different sequences of treatment
Periodo de tiempo: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
|
If the images are available, conduct image peer review to evaluate tumour size retrospectively in different sequences of treatment: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
Peer review time point includes baseline, best response and progression of last image while stopping treatment at each treatment mentioned above.
|
(1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
|
|
The reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review
Periodo de tiempo: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.
|
Evaluate the reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review and compare the difference of reason(s) for the treatment change between initiatial evaluation and after peer review.
|
Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Te-Chun Hsia, China Medical University Hospital
- Investigador principal: Yuh-Min Chen, Taipei Veterans General Hospital, Taiwan
- Investigador principal: Gee-Chen Chang, Veterans General Hospital -Taichung
- Investigador principal: Chong-Jen Yu, National Taiwan University Hospital
- Investigador principal: Cheng-Ta Yang, Chang Gung Memorial Hospital
- Investigador principal: Meng-Chih Lin, Chang-Gung Memorial Hospital Kaohsiung
- Investigador principal: Ying-Huang Tsai, Chang-Gung Memorial Hospital ChiaYi
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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 diciembre de 2013
Finalización primaria (Actual)
1 de agosto de 2014
Finalización del estudio (Actual)
1 de agosto de 2014
Fechas de registro del estudio
Enviado por primera vez
30 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
30 de septiembre de 2013
Publicado por primera vez (Estimar)
7 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
3 de noviembre de 2015
Última verificación
1 de noviembre de 2015
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NIS-OTW-XXX-2013/1
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. .