UMIN-CTR 臨床試験登録情報の閲覧

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 2021/12/20 12:29:14

※ 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。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information

一般向け試験名/Public title

日本語
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.


英語
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

日本語
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.


英語
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

日本語
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.


英語
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

日本語
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.


英語
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

日本語
NSCLC


英語
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

日本語
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.


英語
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

日本語
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.


英語
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

日本語
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.


英語
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

日本語


英語


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

日本語


英語

介入2/Interventions/Control_2

日本語


英語

介入3/Interventions/Control_3

日本語


英語

介入4/Interventions/Control_4

日本語


英語

介入5/Interventions/Control_5

日本語


英語

介入6/Interventions/Control_6

日本語


英語

介入7/Interventions/Control_7

日本語


英語

介入8/Interventions/Control_8

日本語


英語

介入9/Interventions/Control_9

日本語


英語

介入10/Interventions/Control_10

日本語


英語


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

日本語
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.


英語
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

日本語
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.


英語
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

日本語
堀田
ミドルネーム
信之


英語
Nobuyuki
ミドルネーム
Horita

所属組織/Organization

日本語
横浜市立大学


英語
Yokohama City University

所属部署/Division name

日本語
呼吸器内科


英語
Department of Pulmonology

郵便番号/Zip code

236-0004

住所/Address

日本語
横浜市金沢区福浦3-9


英語
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

日本語
堀田
ミドルネーム
信之


英語
Nobuyuki
ミドルネーム
Horiat

組織名/Organization

日本語
横浜市立大学


英語
Yokohama City University

部署名/Division name

日本語
呼吸器内科


英語
Department of Pulmonology

郵便番号/Zip code

236-0004

住所/Address

日本語
横浜市金沢区福浦3-9


英語
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


実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
その他


英語
Yokohama City University

機関名/Institute
(機関選択不可の場合)

日本語
横浜市立大学


部署名/Department

日本語


個人名/Personal name

日本語


英語


研究費提供組織/Funding Source

機関名/Organization

日本語
その他


英語
Yokohama City University

機関名/Organization
(機関選択不可の場合)

日本語
横浜市立大学


組織名/Division

日本語


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

日本語


英語
Japan


その他の関連組織/Other related organizations

共同実施組織/Co-sponsor

日本語


英語

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

日本語


英語


IRB等連絡先(公開)/IRB Contact (For public release)

組織名/Organization

日本語
横浜市立大学


英語
Yokohama City University

住所/Address

日本語
横浜市金沢区福浦3-9


英語
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

日本語


英語

試験ID2/Study ID_2


ID発行機関2/Org. issuing International ID_2

日本語


英語

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

9059

主な結果/Results

日本語


英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.

主な結果入力日/Results date posted

2021 12 20

結果掲載遅延/Results Delayed


結果遅延理由/Results Delay Reason

日本語


英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.

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

日本語


英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.

参加者の流れ/Participant flow

日本語


英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.

有害事象/Adverse events

日本語


英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.

評価項目/Outcome measures

日本語


英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.

個別症例データ共有計画/Plan to share IPD

日本語


英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.

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

日本語


英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.


試験進捗状況/Progress

試験進捗状況/Recruitment status

主たる結果の公表済み/Main results already published

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

2020 05 15

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

日本語
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.


英語
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

2021 12 20



閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046117


英語
https://center6.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