{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T15:14:30Z","timestamp":1791558870114,"version":"4.3.4"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,10,24]],"date-time":"2024-10-24T00:00:00Z","timestamp":1729728000000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009619","name":"AMED","doi-asserted-by":"publisher","award":["24ck0106942"],"award-info":[{"award-number":["24ck0106942"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Cancer Center Research and Development Fund","award":["2023-J-03"],"award-info":[{"award-number":["2023-J-03"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,2,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>In patients with non-small cell lung cancer (NSCLC) who present with radiologically undetermined malignant pleural dissemination or incidental surgical diagnosis of the same, surgery is generally not the preferred option; systemic therapy is favoured. However, there is no consensus on incorporating primary site resection into the treatment plan. Retrospective analyses hint at potential benefits of combining systemic therapy with primary site resection, but prospective studies have yet to confirm these findings. Consequently, we have planned a multicentre, open-label, randomized controlled phase III trial to assess the efficacy of adding primary site resection to standard systemic therapy for stage IVA (cT1-2bN0-1M1a) NSCLC patients with radiologically undetermined pleural dissemination. The primary endpoint is overall survival. We aim to enroll 170 patients from 71 institutions over 5 years. This trial is registered at the Japan Registry of Clinical Trials (jRCT) under study number jRCTs031220666.<\/jats:p>","DOI":"10.1093\/jjco\/hyae143","type":"journal-article","created":{"date-parts":[[2024,10,24]],"date-time":"2024-10-24T07:32:39Z","timestamp":1729755159000},"page":"176-182","source":"Crossref","is-referenced-by-count":3,"title":["Protocol summary of a randomized phase III study: comparing systemic therapy with and without debulking surgery (primary tumour resection) for clinical stage IVA (cT1-2bN0-1M1a) non-small cell lung cancer with radiologically undetermined pleural dissemination JCOG2103 (DEBULK-LUNG)"],"prefix":"10.1093","volume":"55","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8885-4972","authenticated-orcid":false,"given":"Yuta","family":"Sekino","sequence":"first","affiliation":[{"name":"Japan Clinical Oncology Group Data Center\/Operations Office, National Cancer Center Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3417-8563","authenticated-orcid":false,"given":"Tomoyuki","family":"Hishida","sequence":"additional","affiliation":[{"name":"Division of Thoracic Surgery , Department of Surgery, , Tokyo,","place":["Japan"]},{"name":"Keio University School of Medicine , Department of Surgery, , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshige","family":"Yoshioka","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Kansai Medical University Hospital , Hirakata,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Wakabayashi","sequence":"additional","affiliation":[{"name":"Japan Clinical Oncology Group Data Center\/Operations Office, National Cancer Center Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Mitome","sequence":"additional","affiliation":[{"name":"Japan Clinical Oncology Group Data Center\/Operations Office, National Cancer Center Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Shiono","sequence":"additional","affiliation":[{"name":"Department of Surgery II , Faculty of Medicine, , Yamagata,","place":["Japan"]},{"name":"Yamagata University , Faculty of Medicine, , Yamagata,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirotsugu","family":"Kenmotsu","sequence":"additional","affiliation":[{"name":"Division of Thoracic Oncology, Shizuoka Cancer Center , Shizuoka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaname","family":"Nosaki","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, National Cancer Center Hospital East , Chiba,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiju","family":"Aokage","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, National Cancer Center Hospital East , Chiba,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9090-801X","authenticated-orcid":false,"given":"Hidehito","family":"Horinouchi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, National Cancer Center Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haruhiko","family":"Fukuda","sequence":"additional","affiliation":[{"name":"Japan Clinical Oncology Group Data Center\/Operations Office, National Cancer Center Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6137-073X","authenticated-orcid":false,"given":"Yuichiro","family":"Ohe","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, National Cancer Center Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shun-ichi","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, National Cancer Center Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Lung Cancer Surgical Study Group (LCSSG) and the Lung Cancer Study Group (LCSG) of the Japan Clinical Oncology Group (JCOG)","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,10,23]]},"reference":[{"key":"2025051203120621500_ref1","doi-asserted-by":"publisher","first-page":"87","DOI":"10.3322\/caac.21262","article-title":"Global cancer statistics, 2012","volume":"65","author":"Torre","year":"2015","journal-title":"CA Cancer J Clin"},{"key":"2025051203120621500_ref2","doi-asserted-by":"publisher","first-page":"1238","DOI":"10.1016\/j.jtcvs.2017.09.162","article-title":"Lung adenocarcinoma with intraoperatively diagnosed pleural seeding: Is main tumor resection beneficial for prognosis?","volume":"155","author":"Li","year":"2018","journal-title":"J Thorac Cardiovasc Surg"},{"key":"2025051203120621500_ref3","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1186\/s13014-019-1240-1","article-title":"Optimal timing and clinical value of radiotherapy in advanced ALK-rearranged non-small cell lung cancer with or without baseline brain metastases: Implications from pattern of failure analyses","volume":"14","author":"Ni","year":"2019","journal-title":"Radiat Oncol"},{"key":"2025051203120621500_ref4","doi-asserted-by":"publisher","first-page":"1601","DOI":"10.1097\/JTO.0000000000000648","article-title":"Pattern of failure analysis in metastatic EGFR-mutant lung cancer treated with tyrosine kinase inhibitors to identify candidates for consolidation stereotactic body radiation therapy","volume":"10","author":"al-Halabi","year":"2015","journal-title":"J Thorac Oncol"},{"key":"2025051203120621500_ref5","doi-asserted-by":"publisher","first-page":"1062","DOI":"10.1007\/s005950070002","article-title":"The prognosis of patients with non-small cell lung cancer found to have carcinomatous pleuritis at thoracotomy","volume":"30","author":"Ichinose","year":"2000","journal-title":"Surg Today"},{"key":"2025051203120621500_ref6","doi-asserted-by":"publisher","first-page":"1076","DOI":"10.1097\/JTO.0000000000000554","article-title":"Surgical intervention for non-small-cell lung cancer patients with pleural carcinomatosis: Results from the Japanese lung cancer registry in 2004","volume":"10","author":"Iida","year":"2015","journal-title":"J Thorac Oncol"},{"key":"2025051203120621500_ref7","doi-asserted-by":"publisher","first-page":"321","DOI":"10.1093\/icvts\/ivv353","article-title":"Primary tumour resection showed survival benefits for non-small-cell lung cancers with unexpected malignant pleural dissemination","volume":"22","author":"Ren","year":"2016","journal-title":"Interact Cardiovasc Thorac Surg"},{"key":"2025051203120621500_ref8","doi-asserted-by":"publisher","first-page":"5435","DOI":"10.18632\/oncotarget.23686","article-title":"Effect of postoperative systemic therapy on pulmonary adenocarcinoma with unexpected pleural spread detected during thoracotomy or thoracoscopy","volume":"9","author":"Chiang","year":"2018","journal-title":"Oncotarget"},{"key":"2025051203120621500_ref9","doi-asserted-by":"publisher","first-page":"412","DOI":"10.1016\/S0003-4975(01)03426-9","article-title":"Malignant minor pleural effusion detected on thoracotomy for patients with non-small cell lung cancer: Is tumor resection beneficial for prognosis?","volume":"73","author":"Sawabata","year":"2002","journal-title":"Ann Thorac Surg"},{"key":"2025051203120621500_ref10","doi-asserted-by":"publisher","first-page":"113","DOI":"10.1056\/NEJMoa1713137","article-title":"Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer","volume":"378","author":"Soria","year":"2018","journal-title":"N Engl J Med"},{"key":"2025051203120621500_ref11","doi-asserted-by":"publisher","first-page":"1254","DOI":"10.1016\/S1470-2045(14)70402-4","article-title":"Six versus fewer planned cycles of first-line platinum-based chemotherapy for non-small-cell lung cancer: A systematic review and meta-analysis of individual patient data","volume":"15","author":"Rossi","year":"2014","journal-title":"Lancet Oncol"},{"key":"2025051203120621500_ref12","doi-asserted-by":"publisher","first-page":"163","DOI":"10.2307\/2530299","article-title":"Nomograms for calculating the number of patients needed for a clinical trial with survival as an endpoint","volume":"38","author":"Schoenfeld","year":"1982","journal-title":"Biometrics"},{"key":"2025051203120621500_ref13","doi-asserted-by":"publisher","first-page":"659","DOI":"10.2307\/2336502","article-title":"Discrete sequential boundaries for clinical trials","volume":"70","author":"Lan","year":"1983","journal-title":"Biometrika"},{"key":"2025051203120621500_ref14","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1016\/0197-2456(82)90022-8","article-title":"An aid to data monitoring in long-term clinical trials","volume":"3","author":"Halperin","year":"1982","journal-title":"Control Clin Trials"},{"key":"2025051203120621500_ref15","doi-asserted-by":"publisher","first-page":"1501","DOI":"10.1002\/sim.4780121516","article-title":"Applying Bayesian ideas in drug development and clinical trials","volume":"12","author":"Spiegelhalter","year":"1993","journal-title":"Stat Med"}],"container-title":["Japanese Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jjco\/article-pdf\/55\/2\/176\/60011107\/hyae143.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jjco\/article-pdf\/55\/2\/176\/60011107\/hyae143.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,12]],"date-time":"2025-05-12T07:12:15Z","timestamp":1747033935000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jjco\/article\/55\/2\/176\/7833416"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,23]]},"references-count":15,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,10,23]]},"published-print":{"date-parts":[[2025,2,4]]}},"URL":"https:\/\/doi.org\/10.1093\/jjco\/hyae143","relation":{},"ISSN":["1465-3621"],"issn-type":[{"value":"1465-3621","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,2]]},"published":{"date-parts":[[2024,10,23]]}}}