UMIN試験ID | UMIN000052558 |
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受付番号 | R000059968 |
科学的試験名 | Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials |
一般公開日(本登録希望日) | 2023/10/20 |
最終更新日 | 2023/10/20 10:32:50 |
日本語
Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials
英語
Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials
日本語
Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials
英語
Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials
日本語
Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials
英語
Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials
日本語
Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials
英語
Progression-free, disease-free, and recurrence-free survivals as surrogate in NSCLC perioperative chemotherapy trials
日本/Japan |
日本語
非小細胞肺癌
英語
NSCLC
呼吸器内科学/Pneumology | 呼吸器外科学/Chest surgery |
悪性腫瘍/Malignancy
いいえ/NO
日本語
英語参照
英語
Clinical trials have been designed to assess the efficacy and safety of perioperative chemotherapy. The ideal efficacy endpoint is overall survival (OS), as it offers a straightforward, unbiased metric representing patient benefit. Both the U.S. Food and Drug Administration and the European Medicines Agency regard OS as the most reliable endpoint in regulatory evaluations concerning NSCLC chemotherapy. However, unlike patients with advanced lung cancer ineligible for surgery, those undergoing curative-intent surgery have longer life expectancies and a lower incidence of death events. To detect statistical significance in mortality between groups, studies require a long observation period and/or a large patient accrual, making study design challenging. Therefore, surrogate endpoints such as progression-free survival (PFS), disease-free survival (DFS), and recurrence-free survival (RFS) are often selected for the primary outcome of a trial. Recently, immune checkpoint inhibitors (ICI) used as perioperative chemotherapy regimens have been shown to extend patient survival. Consequently, confirming significant differences in OS has become more difficult, making these surrogates increasingly attractive. A fundamental issue in using surrogate endpoints in the perioperative chemotherapy trial is ignoring the limited treatment options available upon recurrence. For example, if DFS is equivalent, patients in the non-perioperative chemotherapy group have a wider array of chemotherapy choices and are expected to have longer OS.
The aim of this systematic review is to assess whether surrogate endpoints are a reasonable in trials involving perioperative chemotherapy for NSCLC.
有効性/Efficacy
日本語
英語
日本語
英文参照
英語
The primary endpoints consist of the correlation between hazard ratios (HRs) of surrogate endpoints and overall survival (OS). The surrogates, namely DFS, RFS, and PFS, will be evaluated collectively for the primary endpoints. DFS, RFS, and PFS will be assessed specifically as part of the subgroup analysis.
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英語
その他・メタアナリシス等/Others,meta-analysis etc
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英語
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英語
日本語
英語
日本語
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日本語
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適用なし/Not applicable |
適用なし/Not applicable |
男女両方/Male and Female
日本語
英文参照
英語
Study Selection//
Any article written in English language presenting a randomized controlled trial (RCT)is considered eligible. Conference abstracts will be accepted for this study. The study phase is not a factor for exclusion.
Patients//
Patients with NSCLC will be evaluated, irrespective of cancer stage, pathological subtype, or driver mutation, as long as the patients were candidates for perioperative chemotherapy according to the authors of the original article.
Treatment//
This study is focused on perioperative chemotherapy, including NAC and AC, regardless of the agents, regimens, and number of cycles used. Cytotoxic agents, molecular targeted therapy (MTT), immune checkpoint inhibitors (ICI), or combinations thereof are acceptable. Any treatment combined with radiotherapy will not be included.
日本語
英語参照
英語
Not specified
日本語
名 | 信之 |
ミドルネーム | |
姓 | 堀田 |
英語
名 | Nobuyuki |
ミドルネーム | |
姓 | Horita |
日本語
横浜市立大学附属病院
英語
Yokohama City University Hospital
日本語
化学療法センター
英語
Chemotherapy Center
236-0004
日本語
横浜市金沢区福浦3-9
英語
3-9, Fukuura, Kanazawa, Yokohama, Japan
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 | Horita |
日本語
横浜市立大学附属病院
英語
Yokohama City University Hospital
日本語
化学療法センター
英語
Chemotherapy Center
236-0004
日本語
横浜市金沢区福浦3-9
英語
3-9, Fukuura, Kanazawa, Yokohama, Japan
045-787-2800
horitano@yokohama-cu.ac.jp
日本語
その他
英語
Yokohama City University Hospital
日本語
横浜市立大学附属病院
日本語
日本語
英語
日本語
横浜市立大学
英語
Yokohama City University Hospital
日本語
横浜市立大学附属病院
日本語
その他/Other
日本語
英語
日本語
英語
日本語
英語
日本語
横浜市立大学附属病院
英語
Yokohama City University Hospital
日本語
横浜市金沢区福浦3-9
英語
3-9, Fukuura, Kanazawa, Yokohama, Japan
045-787-2800
horitano@yokohama-cu.ac.jp
いいえ/NO
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英語
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英語
2023 | 年 | 10 | 月 | 20 | 日 |
未公表/Unpublished
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開始前/Preinitiation
2023 | 年 | 10 | 月 | 10 | 日 |
2023 | 年 | 10 | 月 | 10 | 日 |
2024 | 年 | 12 | 月 | 31 | 日 |
日本語
英語参照
英語
Study Search
We will perform a comprehensive systematic database search in the following databases: PubMed, the Cochrane CENTRAL, EMBASE, and Web of Science.
Subgroup Analysis
We plan to conduct subgroup analyses focusing on the following factors: DFS, RFS, PFS, NAC, AC, MTT, ICI, and phase III trials.
Statistics
We assess surrogacy using the weighted Spearman's rank correlation coefficient (r) between HRos and HRsurrogates. The coefficient is interpreted as follows: no correlation, |r| < 0.2; weak correlation, 0.2 < |r| < 0.4; moderate correlation, 0.4 < |r| < 0.6; strong correlation, 0.6 < |r| < 0.8; or excellent correlation, 0.8 < |r|. The correlation was assessed for original data, and then the correlation after reciprocal duplication will be calculated to avoid underestimation of r. The weight assigned to each study was determined by the reciprocal of the squared standard error (SE) of log HRos. The "corr" command within the "boot" package in the R software will be applied. GraphPad Prism version 9.2.0 (GraphPad Software, San Diego, CA, USA) is used to generate figures.
2023 | 年 | 10 | 月 | 20 | 日 |
2023 | 年 | 10 | 月 | 20 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000059968
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059968
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