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A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)

3 listopada 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Locally Advanced or Metastatic EGFR Mutated NSCLC.

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Oczekiwany)

200

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Tajwan
- - Chiayi, Tajwan
  - Kaohsiung, Tajwan
  - Taichung, Tajwan
  - Taipei, Tajwan
  - Taipei, Tajwan
    - Research Site
  - Tao Yuan, Tajwan

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 150 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration Ramy czasowe: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	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.	From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. Ramy czasowe: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	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.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. Ramy czasowe: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	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.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. Ramy czasowe: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	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.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. Ramy czasowe: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	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).	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy. Ramy czasowe: Between the initial EGFR-TKI therapy and first time chemotherapy.	Treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.	Between the initial EGFR-TKI therapy and first time chemotherapy.
Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment). Ramy czasowe: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics. Ramy czasowe: EGFR-TKI initial and re-administration	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)	EGFR-TKI initial and re-administration
overall survival (OS), plasma CEA level and chemotherapy regimens ever used. Ramy czasowe: between first time chemotherapy and EGFR-TKI re-administration	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.	between first time chemotherapy and EGFR-TKI re-administration
image peer review to evaluate tumour size retrospectively in different sequences of treatment Ramy czasowe: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.	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.	(1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
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 Ramy czasowe: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.	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.	Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Śledczy

Główny śledczy: Te-Chun Hsia, China Medical University Hospital
Główny śledczy: Yuh-Min Chen, Taipei Veterans General Hospital, Taiwan
Główny śledczy: Gee-Chen Chang, Veterans General Hospital -Taichung
Główny śledczy: Chong-Jen Yu, National Taiwan University Hospital
Główny śledczy: Cheng-Ta Yang, Chang Gung Memorial Hospital
Główny śledczy: Meng-Chih Lin, Chang-Gung Memorial Hospital Kaohsiung
Główny śledczy: Ying-Huang Tsai, Chang-Gung Memorial Hospital ChiaYi

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

CSR_Synopsis_NIS-OTW-XXX-2013_1

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 2013

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2014

Ukończenie studiów (Rzeczywisty)