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 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
200
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Chiayi, Taïwan
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Kaohsiung, Taïwan
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Taichung, Taïwan
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Taipei, Taïwan
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Taipei, Taïwan
- Research Site
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Tao Yuan, Taïwan
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 150 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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).
Délai: 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.
Délai: 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.
Délai: 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
Délai: (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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Te-Chun Hsia, China Medical University Hospital
- Chercheur principal: Yuh-Min Chen, Taipei Veterans General Hospital, Taiwan
- Chercheur principal: Gee-Chen Chang, Veterans General Hospital -Taichung
- Chercheur principal: Chong-Jen Yu, National Taiwan University Hospital
- Chercheur principal: Cheng-Ta Yang, Chang Gung Memorial Hospital
- Chercheur principal: Meng-Chih Lin, Chang-Gung Memorial Hospital Kaohsiung
- Chercheur principal: Ying-Huang Tsai, Chang-Gung Memorial Hospital ChiaYi
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2013
Achèvement primaire (Réel)
1 août 2014
Achèvement de l'étude (Réel)
1 août 2014
Dates d'inscription aux études
Première soumission
30 septembre 2013
Première soumission répondant aux critères de contrôle qualité
30 septembre 2013
Première publication (Estimation)
7 octobre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 novembre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 novembre 2015
Dernière vérification
1 novembre 2015
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- NIS-OTW-XXX-2013/1
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .