A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)
3. listopadu 2015 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Očekávaný)
200
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Chiayi, Tchaj-wan
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Kaohsiung, Tchaj-wan
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Taichung, Tchaj-wan
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Taipei, Tchaj-wan
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Taipei, Tchaj-wan
- Research Site
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Tao Yuan, Tchaj-wan
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let až 150 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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).
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: (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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Te-Chun Hsia, China Medical University Hospital
- Vrchní vyšetřovatel: Yuh-Min Chen, Taipei Veterans General Hospital, Taiwan
- Vrchní vyšetřovatel: Gee-Chen Chang, Veterans General Hospital -Taichung
- Vrchní vyšetřovatel: Chong-Jen Yu, National Taiwan University Hospital
- Vrchní vyšetřovatel: Cheng-Ta Yang, Chang Gung Memorial Hospital
- Vrchní vyšetřovatel: Meng-Chih Lin, Chang-Gung Memorial Hospital Kaohsiung
- Vrchní vyšetřovatel: Ying-Huang Tsai, Chang-Gung Memorial Hospital ChiaYi
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2013
Primární dokončení (Aktuální)
1. srpna 2014
Dokončení studie (Aktuální)
1. srpna 2014
Termíny zápisu do studia
První předloženo
30. září 2013
První předloženo, které splnilo kritéria kontroly kvality
30. září 2013
První zveřejněno (Odhad)
7. října 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
4. listopadu 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. listopadu 2015
Naposledy ověřeno
1. listopadu 2015
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- NIS-OTW-XXX-2013/1
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