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UMIN ID:

試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000040412
受付番号 R000046117
科学的試験名 Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer.
一般公開日(本登録希望日) 2020/05/15
最終更新日 2020/05/15

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
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基本情報/Basic information
一般向け試験名/Public title Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer. Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer.
一般向け試験名略称/Acronym Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer. Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer.
科学的試験名/Scientific Title Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer. Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer.
科学的試験名略称/Scientific Title:Acronym Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer. Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer.
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition NSCLC NSCLC
疾患区分1/Classification by specialty
呼吸器内科学/Pneumology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 Although objective response rate (ORR) and disease control rate (DCR) are frequently used as primary endpoints of phase II randomized non-small cell lung cancer (NSCLC)trials that evaluate second- or later-line chemotherapy, how ORR and DCR reflect overall survival (OS) in the phase II trial have not been sufficiently assessed. We are quite unsure whether ORR and DCR correctly associate with the OS in NSCLC phase II trials evaluating second- or later-line chemotherapy. ORR and DCR seem unreliable due to a low ORR, a poor DCR, and small number of evaluated patients in phase II trials for cases after first-line relapse.
In this study, we evaluate how trial-level ORR and DCR correlate with OS in the phase II randomized NSCLC trials that evaluate second- or later-line chemotherapy.
Although objective response rate (ORR) and disease control rate (DCR) are frequently used as primary endpoints of phase II randomized non-small cell lung cancer (NSCLC)trials that evaluate second- or later-line chemotherapy, how ORR and DCR reflect overall survival (OS) in the phase II trial have not been sufficiently assessed. We are quite unsure whether ORR and DCR correctly associate with the OS in NSCLC phase II trials evaluating second- or later-line chemotherapy. ORR and DCR seem unreliable due to a low ORR, a poor DCR, and small number of evaluated patients in phase II trials for cases after first-line relapse.
In this study, we evaluate how trial-level ORR and DCR correlate with OS in the phase II randomized NSCLC trials that evaluate second- or later-line chemotherapy.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others Although objective response rate (ORR) and disease control rate (DCR) are frequently used as primary endpoints of phase II randomized non-small cell lung cancer (NSCLC)trials that evaluate second- or later-line chemotherapy, how ORR and DCR reflect overall survival (OS) in the phase II trial have not been sufficiently assessed. We are quite unsure whether ORR and DCR correctly associate with the OS in NSCLC phase II trials evaluating second- or later-line chemotherapy. ORR and DCR seem unreliable due to a low ORR, a poor DCR, and small number of evaluated patients in phase II trials for cases after first-line relapse.
In this study, we evaluate how trial-level ORR and DCR correlate with OS in the phase II randomized NSCLC trials that evaluate second- or later-line chemotherapy.
Although objective response rate (ORR) and disease control rate (DCR) are frequently used as primary endpoints of phase II randomized non-small cell lung cancer (NSCLC)trials that evaluate second- or later-line chemotherapy, how ORR and DCR reflect overall survival (OS) in the phase II trial have not been sufficiently assessed. We are quite unsure whether ORR and DCR correctly associate with the OS in NSCLC phase II trials evaluating second- or later-line chemotherapy. ORR and DCR seem unreliable due to a low ORR, a poor DCR, and small number of evaluated patients in phase II trials for cases after first-line relapse.
In this study, we evaluate how trial-level ORR and DCR correlate with OS in the phase II randomized NSCLC trials that evaluate second- or later-line chemotherapy.
試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes Correlation with hazard ratio (HR) for OS (HRos) of odds ratio of RR (ORrr), odds ratio of DCR(ORdcr), difference of RR (d-RR, %), and difference of DCR (d-RCR, %) were assessed. Response, stable disease, and disease progression had to be evaluated without considerable deviation from the Response Evaluation Criteria in Solid Tumors (RECIST) 2000 guidelines and the RECIST 2009 revised guidelines. Correlation with hazard ratio (HR) for OS (HRos) of odds ratio of RR (ORrr), odds ratio of DCR(ORdcr), difference of RR (d-RR, %), and difference of DCR (d-RCR, %) were assessed. Response, stable disease, and disease progression had to be evaluated without considerable deviation from the Response Evaluation Criteria in Solid Tumors (RECIST) 2000 guidelines and the RECIST 2009 revised guidelines.
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type その他・メタアナリシス等/Others,meta-analysis etc

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit

適用なし/Not applicable
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria Study Selection: study design
We will include phase II RCTs that evaluate second- or later-line chemotherapy for advanced, locally advanced, and recurrent NSCLC. Articles need to be written up as full articles, brief reports, or conference abstracts regardless of their primary end point. Non-English language reports will be excluded. A phase I/II trial will be allowed. A phase II/III trial will be included when data from phase II part can be extractable

Study selection: treatment
The interventions include cytotoxic agents, molecular targeted therapies, immune checkpoint inhibitors, and their combinations. Immunotherapy other than immune checkpoint inhibitors will not be included because such treatment is not current standard. Comparison of the same drugs in the form of low-dose versus high-dose or weekly versus 3-weekly regimens will be allowed. Maintenance therapy after the first-line chemotherapy will not considered as the second-line treatment.
Study Selection: study design
We will include phase II RCTs that evaluate second- or later-line chemotherapy for advanced, locally advanced, and recurrent NSCLC. Articles need to be written up as full articles, brief reports, or conference abstracts regardless of their primary end point. Non-English language reports will be excluded. A phase I/II trial will be allowed. A phase II/III trial will be included when data from phase II part can be extractable

Study selection: treatment
The interventions include cytotoxic agents, molecular targeted therapies, immune checkpoint inhibitors, and their combinations. Immunotherapy other than immune checkpoint inhibitors will not be included because such treatment is not current standard. Comparison of the same drugs in the form of low-dose versus high-dose or weekly versus 3-weekly regimens will be allowed. Maintenance therapy after the first-line chemotherapy will not considered as the second-line treatment.
除外基準/Key exclusion criteria Study Selection: study design
We will include phase II RCTs that evaluate second- or later-line chemotherapy for advanced, locally advanced, and recurrent NSCLC. Articles need to be written up as full articles, brief reports, or conference abstracts regardless of their primary end point. Non-English language reports will be excluded. A phase I/II trial will be allowed. A phase II/III trial will be included when data from phase II part can be extractable

Study selection: treatment
The interventions include cytotoxic agents, molecular targeted therapies, immune checkpoint inhibitors, and their combinations. Immunotherapy other than immune checkpoint inhibitors will not be included because such treatment is not current standard. Comparison of the same drugs in the form of low-dose versus high-dose or weekly versus 3-weekly regimens will be allowed. Maintenance therapy after the first-line chemotherapy will not considered as the second-line treatment.
Study Selection: study design
We will include phase II RCTs that evaluate second- or later-line chemotherapy for advanced, locally advanced, and recurrent NSCLC. Articles need to be written up as full articles, brief reports, or conference abstracts regardless of their primary end point. Non-English language reports will be excluded. A phase I/II trial will be allowed. A phase II/III trial will be included when data from phase II part can be extractable

Study selection: treatment
The interventions include cytotoxic agents, molecular targeted therapies, immune checkpoint inhibitors, and their combinations. Immunotherapy other than immune checkpoint inhibitors will not be included because such treatment is not current standard. Comparison of the same drugs in the form of low-dose versus high-dose or weekly versus 3-weekly regimens will be allowed. Maintenance therapy after the first-line chemotherapy will not considered as the second-line treatment.
目標参加者数/Target sample size

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
堀田
ミドルネーム
信之
Nobuyuki
ミドルネーム
Horita
所属組織/Organization 横浜市立大学 Yokohama City University
所属部署/Division name 呼吸器内科 Department of Pulmonology
郵便番号/Zip code 236-0004
住所/Address 横浜市金沢区福浦3-9 3-9, Fukuura, Kanazawa, Yokohama
電話/TEL 045-787-2800
Email/Email horitano@yokohama-cu.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
堀田
ミドルネーム
信之
Nobuyuki
ミドルネーム
Horiat
組織名/Organization 横浜市立大学 Yokohama City University
部署名/Division name 呼吸器内科 Department of Pulmonology
郵便番号/Zip code 236-0004
住所/Address 横浜市金沢区福浦3-9 3-9, Fukuura, Kanazawa, Yokohama
電話/TEL 045-787-2800
試験のホームページURL/Homepage URL
Email/Email horitano@yokohama-cu.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Yokohama City University
機関名/Institute
(機関選択不可の場合)
横浜市立大学
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Yokohama City University
機関名/Organization
(機関選択不可の場合)
横浜市立大学
組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization
Japan

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 横浜市立大学 Yokohama City University
住所/Address 横浜市金沢区福浦3-9 3-9, Fukuura, Kanazawa, Yokohama
電話/Tel 0457872800
Email/Email horitano@yokohama-cu.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 05 15

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2020 05 15
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2020 05 15
フォロー終了(予定)日/Last follow-up date
2021 05 15
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information This study will be conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Study Search
We will systematically search PubMed, the Cochrane database, EMBASE, and Web of Science as of May 15, 2020. The search formula for PubMed is the followings: (Non Small Cell Lung Cancer OR Non Small Cell Lung Carcinoma OR NSCLC OR Adenocarcinoma of Lung OR Squamous carcinoma of lung) AND (Recurrent OR Recurrence OR relapsed OR Advanced OR Advance OR Metastatic OR Metastasis OR Stage IV OR Stage III OR Stage four OR Stage three) AND (Phase II OR Phase two OR Phase 2) AND (Randomized OR Randomised OR Randomly OR RCT) AND (2nd line OR Second line OR 3rd line OR Third line OR later line). Reference lists in the included articles were also checked as hand search.

Assessment of Risk for Bias in Included Studies
Risk for bias in individual RCTs will be evaluated using the Cochrane risk of bias table.


Data Extraction
Data will be extracted by the two investigators independently and cross-checked.
We prefer OS data obtained on the basis of predeclared timing of each original trial.
The first arm and the second arm of each RCT will be decided according to the description in each article. If an article randomized patients into three or more arms, the two arms with the largest number of patients were extracted. ORR and DCR will be preferably determined by full-analysis set or intention-to-treat policy; thus, a denominator includes not-evaluable patients.
If necessary, we adopt Parmar's method to extract data from Kaplan-Meier curves [PMID: 9921604]

Data Synthesis and Interpretation
Spearman's rank correlation will be calculated using GraphPad PRISM ver 7.02 (San Diego, CA, USA). When one or more cells in the two by two contingency to calculate ORR and DCR were null, 0.5 was added.
This study will be conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Study Search
We will systematically search PubMed, the Cochrane database, EMBASE, and Web of Science as of May 15, 2020. The search formula for PubMed is the followings: (Non Small Cell Lung Cancer OR Non Small Cell Lung Carcinoma OR NSCLC OR Adenocarcinoma of Lung OR Squamous carcinoma of lung) AND (Recurrent OR Recurrence OR relapsed OR Advanced OR Advance OR Metastatic OR Metastasis OR Stage IV OR Stage III OR Stage four OR Stage three) AND (Phase II OR Phase two OR Phase 2) AND (Randomized OR Randomised OR Randomly OR RCT) AND (2nd line OR Second line OR 3rd line OR Third line OR later line). Reference lists in the included articles were also checked as hand search.

Assessment of Risk for Bias in Included Studies
Risk for bias in individual RCTs will be evaluated using the Cochrane risk of bias table.


Data Extraction
Data will be extracted by the two investigators independently and cross-checked.
We prefer OS data obtained on the basis of predeclared timing of each original trial.
The first arm and the second arm of each RCT will be decided according to the description in each article. If an article randomized patients into three or more arms, the two arms with the largest number of patients were extracted. ORR and DCR will be preferably determined by full-analysis set or intention-to-treat policy; thus, a denominator includes not-evaluable patients.
If necessary, we adopt Parmar's method to extract data from Kaplan-Meier curves [PMID: 9921604]

Data Synthesis and Interpretation
Spearman's rank correlation will be calculated using GraphPad PRISM ver 7.02 (San Diego, CA, USA). When one or more cells in the two by two contingency to calculate ORR and DCR were null, 0.5 was added.

管理情報/Management information
登録日時/Registered date
2020 05 15
最終更新日/Last modified on
2020 05 15


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046117
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046117

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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