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 |
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.
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.
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.
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.
日本/Japan |
日本語
NSCLC
英語
NSCLC
呼吸器内科学/Pneumology |
悪性腫瘍/Malignancy
いいえ/NO
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.
その他/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.
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.
日本語
英語
その他・メタアナリシス等/Others,meta-analysis etc
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
適用なし/Not applicable |
適用なし/Not applicable |
男女両方/Male and Female
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.
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.
日本語
名 | 堀田 |
ミドルネーム | |
姓 | 信之 |
英語
名 | Nobuyuki |
ミドルネーム | |
姓 | Horita |
日本語
横浜市立大学
英語
Yokohama City University
日本語
呼吸器内科
英語
Department of Pulmonology
236-0004
日本語
横浜市金沢区福浦3-9
英語
3-9, Fukuura, Kanazawa, Yokohama
045-787-2800
horitano@yokohama-cu.ac.jp
日本語
名 | 堀田 |
ミドルネーム | |
姓 | 信之 |
英語
名 | Nobuyuki |
ミドルネーム | |
姓 | Horiat |
日本語
横浜市立大学
英語
Yokohama City University
日本語
呼吸器内科
英語
Department of Pulmonology
236-0004
日本語
横浜市金沢区福浦3-9
英語
3-9, Fukuura, Kanazawa, Yokohama
045-787-2800
horitano@yokohama-cu.ac.jp
日本語
その他
英語
Yokohama City University
日本語
横浜市立大学
日本語
日本語
英語
日本語
その他
英語
Yokohama City University
日本語
横浜市立大学
日本語
自己調達/Self funding
日本語
英語
Japan
日本語
英語
日本語
英語
日本語
横浜市立大学
英語
Yokohama City University
日本語
横浜市金沢区福浦3-9
英語
3-9, Fukuura, Kanazawa, Yokohama
0457872800
horitano@yokohama-cu.ac.jp
いいえ/NO
日本語
英語
日本語
英語
2020 | 年 | 05 | 月 | 15 | 日 |
未公表/Unpublished
9059
日本語
英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
2021 | 年 | 12 | 月 | 20 | 日 |
日本語
英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
日本語
英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
日本語
英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
日本語
英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
日本語
英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
日本語
英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
日本語
英語
Please see:
Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
主たる結果の公表済み/Main results already published
2020 | 年 | 05 | 月 | 15 | 日 |
2020 | 年 | 05 | 月 | 15 | 日 |
2020 | 年 | 05 | 月 | 15 | 日 |
2021 | 年 | 05 | 月 | 15 | 日 |
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.
2020 | 年 | 05 | 月 | 15 | 日 |
2021 | 年 | 12 | 月 | 20 | 日 |
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
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