A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)
3. november 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 150 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: (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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Te-Chun Hsia, China Medical University Hospital
- Ledende efterforsker: Yuh-Min Chen, Taipei Veterans General Hospital, Taiwan
- Ledende efterforsker: Gee-Chen Chang, Veterans General Hospital -Taichung
- Ledende efterforsker: Chong-Jen Yu, National Taiwan University Hospital
- Ledende efterforsker: Cheng-Ta Yang, Chang Gung Memorial Hospital
- Ledende efterforsker: Meng-Chih Lin, Chang-Gung Memorial Hospital Kaohsiung
- Ledende efterforsker: Ying-Huang Tsai, Chang-Gung Memorial Hospital ChiaYi
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2013
Primær færdiggørelse (Faktiske)
1. august 2014
Studieafslutning (Faktiske)
1. august 2014
Datoer for studieregistrering
Først indsendt
30. september 2013
Først indsendt, der opfyldte QC-kriterier
30. september 2013
Først opslået (Skøn)
7. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NIS-OTW-XXX-2013/1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .