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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)

2015年11月3日更新者：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.

調査の概要

状態

完了

条件

Locally Advanced or Metastatic EGFR Mutated NSCLC.

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

200

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

台湾
- - Chiayi、台湾
  - Kaohsiung、台湾
  - Taichung、台湾
  - Taipei、台湾
  - Taipei、台湾
    - Research Site
  - Tao Yuan、台湾

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年～150年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration 時間枠：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.

二次結果の測定

結果測定	メジャーの説明	時間枠
Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 時間枠：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. 時間枠：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. 時間枠：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. 時間枠：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. 時間枠：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). 時間枠：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. 時間枠：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. 時間枠：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 時間枠：(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 時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AstraZeneca

捜査官

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

CSR_Synopsis_NIS-OTW-XXX-2013_1

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年12月1日

一次修了 (実際)

2014年8月1日

研究の完了 (実際)

2014年8月1日

試験登録日

最初に提出

2013年9月30日

QC基準を満たした最初の提出物