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 novembro de 2015 atualizado 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.
Visão geral do estudo
Status
Concluído
Descrição detalhada
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 estudo
Observacional
Inscrição (Antecipado)
200
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Chiayi, Taiwan
-
Kaohsiung, Taiwan
-
Taichung, Taiwan
-
Taipei, Taiwan
-
Taipei, Taiwan
- Research Site
-
Tao Yuan, Taiwan
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 150 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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).
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: (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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2013
Conclusão Primária (Real)
1 de agosto de 2014
Conclusão do estudo (Real)
1 de agosto de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
30 de setembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de setembro de 2013
Primeira postagem (Estimativa)
7 de outubro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
4 de novembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de novembro de 2015
Última verificação
1 de novembro de 2015
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- NIS-OTW-XXX-2013/1
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .