A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)
tiistai 3. marraskuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Odotettu)
200
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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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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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
20 vuotta - 150 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
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
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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).
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: (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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Te-Chun Hsia, China Medical University Hospital
- Päätutkija: Yuh-Min Chen, Taipei Veterans General Hospital, Taiwan
- Päätutkija: Gee-Chen Chang, Veterans General Hospital -Taichung
- Päätutkija: Chong-Jen Yu, National Taiwan University Hospital
- Päätutkija: Cheng-Ta Yang, Chang Gung Memorial Hospital
- Päätutkija: Meng-Chih Lin, Chang-Gung Memorial Hospital Kaohsiung
- Päätutkija: Ying-Huang Tsai, Chang-Gung Memorial Hospital ChiaYi
Julkaisuja ja hyödyllisiä linkkejä
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Hyödyllisiä linkkejä
Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. joulukuuta 2013
Ensisijainen valmistuminen (Todellinen)
Perjantai 1. elokuuta 2014
Opintojen valmistuminen (Todellinen)
Perjantai 1. elokuuta 2014
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 30. syyskuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 30. syyskuuta 2013
Ensimmäinen Lähetetty (Arvio)
Maanantai 7. lokakuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 4. marraskuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 3. marraskuuta 2015
Viimeksi vahvistettu
Sunnuntai 1. marraskuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- NIS-OTW-XXX-2013/1
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