{"title":"一项多机构、随机、III 期试验,比较解剖学分段切除术和肺叶切除术治疗临床 IA3 期纯固性非小细胞肺癌:西日本肿瘤学组研究 WJOG16923L(STEP UP 试验)","authors":"Atsushi Kamigaichi , Akira Hamada , Masahiro Tsuboi , Kenichi Yoshimura , Isamu Okamoto , Nobuyuki Yamamoto , Yasuhiro Tsutani","doi":"10.1016/j.cllc.2024.01.004","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Although the standard treatment for patients with resectable early-stage non–small-cell lung cancer (NSCLC) is pulmonary lobectomy, recent clinical trials have demonstrated the efficacy of anatomical segmentectomy for small-sized early-stage NSCLC measuring ≤2 cm. Segmentectomy is gaining attention as an alternative procedure to lobectomy for early-stage NSCLC.</p></div><div><h3>Patients and Methods</h3><p>In January 2024, we have initiated a randomized phase III trial in Japan to confirm the noninferiority of anatomical segmentectomy to lobectomy in patients with peripheral clinical stage IA3 pure-solid NSCLC (tumor measuring >2 cm and ≤3 cm; consolidation-to-tumor ratio = 1.0). We plan to enroll 520 patients from 61 institutions over a period of 5 years. The primary endpoint is overall survival, and the secondary endpoints include relapse-free survival, postoperative respiratory function, proportion of patients with respiratory failure and cerebrovascular disease, cumulative incidence of death from other diseases, cumulative incidence of local recurrence, proportion of patients who undergo segmentectomy, number of resected segments, operative time, blood loss, and adverse events. This trial has been registered in the UMIN Clinical Trials Registry under the code UMIN000052064.</p></div><div><h3>Conclusions</h3><p>This trial will help establish a novel treatment strategy for patients with peripheral clinical stage IA3 pure-solid NSCLC.</p></div>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1525730424000068/pdfft?md5=78a57e598c599ded5242ff5d6a7a1709&pid=1-s2.0-S1525730424000068-main.pdf","citationCount":"0","resultStr":"{\"title\":\"A Multi-Institutional, Randomized, Phase III Trial Comparing Anatomical Segmentectomy and Lobectomy for Clinical Stage IA3 Pure-Solid Non–Small-Cell Lung Cancer: West Japan Oncology Group Study WJOG16923L (STEP UP Trial)\",\"authors\":\"Atsushi Kamigaichi , Akira Hamada , Masahiro Tsuboi , Kenichi Yoshimura , Isamu Okamoto , Nobuyuki Yamamoto , Yasuhiro Tsutani\",\"doi\":\"10.1016/j.cllc.2024.01.004\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Although the standard treatment for patients with resectable early-stage non–small-cell lung cancer (NSCLC) is pulmonary lobectomy, recent clinical trials have demonstrated the efficacy of anatomical segmentectomy for small-sized early-stage NSCLC measuring ≤2 cm. Segmentectomy is gaining attention as an alternative procedure to lobectomy for early-stage NSCLC.</p></div><div><h3>Patients and Methods</h3><p>In January 2024, we have initiated a randomized phase III trial in Japan to confirm the noninferiority of anatomical segmentectomy to lobectomy in patients with peripheral clinical stage IA3 pure-solid NSCLC (tumor measuring >2 cm and ≤3 cm; consolidation-to-tumor ratio = 1.0). We plan to enroll 520 patients from 61 institutions over a period of 5 years. The primary endpoint is overall survival, and the secondary endpoints include relapse-free survival, postoperative respiratory function, proportion of patients with respiratory failure and cerebrovascular disease, cumulative incidence of death from other diseases, cumulative incidence of local recurrence, proportion of patients who undergo segmentectomy, number of resected segments, operative time, blood loss, and adverse events. This trial has been registered in the UMIN Clinical Trials Registry under the code UMIN000052064.</p></div><div><h3>Conclusions</h3><p>This trial will help establish a novel treatment strategy for patients with peripheral clinical stage IA3 pure-solid NSCLC.</p></div>\",\"PeriodicalId\":10490,\"journal\":{\"name\":\"Clinical lung cancer\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-01-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1525730424000068/pdfft?md5=78a57e598c599ded5242ff5d6a7a1709&pid=1-s2.0-S1525730424000068-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical lung cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1525730424000068\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical lung cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1525730424000068","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
A Multi-Institutional, Randomized, Phase III Trial Comparing Anatomical Segmentectomy and Lobectomy for Clinical Stage IA3 Pure-Solid Non–Small-Cell Lung Cancer: West Japan Oncology Group Study WJOG16923L (STEP UP Trial)
Introduction
Although the standard treatment for patients with resectable early-stage non–small-cell lung cancer (NSCLC) is pulmonary lobectomy, recent clinical trials have demonstrated the efficacy of anatomical segmentectomy for small-sized early-stage NSCLC measuring ≤2 cm. Segmentectomy is gaining attention as an alternative procedure to lobectomy for early-stage NSCLC.
Patients and Methods
In January 2024, we have initiated a randomized phase III trial in Japan to confirm the noninferiority of anatomical segmentectomy to lobectomy in patients with peripheral clinical stage IA3 pure-solid NSCLC (tumor measuring >2 cm and ≤3 cm; consolidation-to-tumor ratio = 1.0). We plan to enroll 520 patients from 61 institutions over a period of 5 years. The primary endpoint is overall survival, and the secondary endpoints include relapse-free survival, postoperative respiratory function, proportion of patients with respiratory failure and cerebrovascular disease, cumulative incidence of death from other diseases, cumulative incidence of local recurrence, proportion of patients who undergo segmentectomy, number of resected segments, operative time, blood loss, and adverse events. This trial has been registered in the UMIN Clinical Trials Registry under the code UMIN000052064.
Conclusions
This trial will help establish a novel treatment strategy for patients with peripheral clinical stage IA3 pure-solid NSCLC.
期刊介绍:
Clinical Lung Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of lung cancer. Clinical Lung Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of lung cancer. The main emphasis is on recent scientific developments in all areas related to lung cancer. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.