A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)
3 novembre 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Anticipato)
200
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Chiayi, Taiwan
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
- Research Site
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Tao Yuan, Taiwan
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 20 anni a 150 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
Lasso di tempo: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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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.
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From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Lasso di tempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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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.
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From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Lasso di tempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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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.
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From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Lasso di tempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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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.
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From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Lasso di tempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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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).
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From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.
Lasso di tempo: Between the initial EGFR-TKI therapy and first time chemotherapy.
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Treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.
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Between the initial EGFR-TKI therapy and first time chemotherapy.
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Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).
Lasso di tempo: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).
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From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
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Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics.
Lasso di tempo: EGFR-TKI initial and re-administration
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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)
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EGFR-TKI initial and re-administration
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overall survival (OS), plasma CEA level and chemotherapy regimens ever used.
Lasso di tempo: between first time chemotherapy and EGFR-TKI re-administration
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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.
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between first time chemotherapy and EGFR-TKI re-administration
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image peer review to evaluate tumour size retrospectively in different sequences of treatment
Lasso di tempo: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
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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.
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(1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
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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
Lasso di tempo: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.
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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.
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Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Te-Chun Hsia, China Medical University Hospital
- Investigatore principale: Yuh-Min Chen, Taipei Veterans General Hospital, Taiwan
- Investigatore principale: Gee-Chen Chang, Veterans General Hospital -Taichung
- Investigatore principale: Chong-Jen Yu, National Taiwan University Hospital
- Investigatore principale: Cheng-Ta Yang, Chang Gung Memorial Hospital
- Investigatore principale: Meng-Chih Lin, Chang-Gung Memorial Hospital Kaohsiung
- Investigatore principale: Ying-Huang Tsai, Chang-Gung Memorial Hospital ChiaYi
Pubblicazioni e link utili
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2013
Completamento primario (Effettivo)
1 agosto 2014
Completamento dello studio (Effettivo)
1 agosto 2014
Date di iscrizione allo studio
Primo inviato
30 settembre 2013
Primo inviato che soddisfa i criteri di controllo qualità
30 settembre 2013
Primo Inserito (Stima)
7 ottobre 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
4 novembre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 novembre 2015
Ultimo verificato
1 novembre 2015
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- NIS-OTW-XXX-2013/1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .