{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T07:52:36Z","timestamp":1784879556685,"version":"3.55.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2022,5,29]],"date-time":"2022-05-29T00:00:00Z","timestamp":1653782400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP22ck0106615"],"award-info":[{"award-number":["JP22ck0106615"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP17ck0106156"],"award-info":[{"award-number":["JP17ck0106156"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008903","name":"Ministry of Health and Welfare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008903","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008746","name":"National Cancer Center","doi-asserted-by":"publisher","award":["2020-J-3"],"award-info":[{"award-number":["2020-J-3"]}],"id":[{"id":"10.13039\/100008746","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008746","name":"National Cancer Center","doi-asserted-by":"publisher","award":["29-A-3"],"award-info":[{"award-number":["29-A-3"]}],"id":[{"id":"10.13039\/100008746","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008746","name":"National Cancer Center","doi-asserted-by":"publisher","award":["26-A-4"],"award-info":[{"award-number":["26-A-4"]}],"id":[{"id":"10.13039\/100008746","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008746","name":"National Cancer Center","doi-asserted-by":"publisher","award":["23-A-19"],"award-info":[{"award-number":["23-A-19"]}],"id":[{"id":"10.13039\/100008746","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,8,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>The optimal perioperative chemotherapy for lower rectal cancer with lateral pelvic lymph node metastasis remains unclear. We evaluated the efficacy and safety of perioperative mFOLFOX6 in comparison with postoperative mFOLFOX6 for rectal cancer patients undergoing total mesorectal excision with lateral lymph node dissection.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted an open label randomized phase II\/III trial in 18 Japanese institutions. We enrolled patients with histologically proven lower rectal adenocarcinoma with clinical pelvic lateral lymph node metastasis who were randomly assigned (1:1) to receive postoperative mFOLFOX6 (12 courses of intravenous oxaliplatin [85\u00a0mg\/m2] with L-leucovorin [200\u00a0mg\/m2] followed by 5-fluorouracil [400\u00a0mg\/m2, bolus and 2400\u00a0mg\/m2, continuous infusion, repeated every 2\u00a0weeks]) or perioperative mFOLFOX6 (six courses each preoperatively and postoperatively). The primary endpoint was overall survival (OS). The trial is registered with Japan Registry of Clinical Trials, number jRCTs031180230.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Between May 2015, and May 2019, 48 patients were randomized to the postoperative arm (n\u00a0=\u00a026) and the perioperative arm (n\u00a0=\u00a022). The trial was terminated prematurely due to poor accrual. The 3-year OS in the postoperative and perioperative groups were 66.1 and 84.4%, respectively (HR 0.58, 95% CI [0.14\u20132.45], one-sided P\u00a0=\u00a00.23). The pathological complete response rate in the perioperative group was 9.1%. Grade 3 postoperative surgical complications were more frequently observed in the perioperative arm (50.0 vs. 12.0%). One treatment-related death due to sepsis from pelvic infection occurred in the postoperative group.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Perioperative mFOLFOX6 may be an insufficient treatment to improve survival of lower rectal cancer with lateral pelvic lymph node metastasis.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyac080","type":"journal-article","created":{"date-parts":[[2022,5,31]],"date-time":"2022-05-31T21:17:57Z","timestamp":1654031877000},"page":"850-858","source":"Crossref","is-referenced-by-count":5,"title":["A randomized controlled trial comparing perioperative vs. postoperative mFOLFOX6 for lower rectal cancer with suspected lateral pelvic lymph node metastasis (JCOG1310): a phase II\/III randomized controlled trial"],"prefix":"10.1093","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9134-3292","authenticated-orcid":false,"given":"Masayuki","family":"Ohue","sequence":"first","affiliation":[{"name":"Department of Gastroenterological Surgery , Osaka International Cancer Institute, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Iwasa","sequence":"additional","affiliation":[{"name":"Gastrointestinal Medical Oncology Division , National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junki","family":"Mizusawa","sequence":"additional","affiliation":[{"name":"Japan Clinical Oncology Group Data Center\/Operations Office , National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukihide","family":"Kanemitsu","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery , National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manabu","family":"Shiozawa","sequence":"additional","affiliation":[{"name":"Department of Surgery , Kanagawa Cancer Center, Yokohama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusuke","family":"Nishizawa","sequence":"additional","affiliation":[{"name":"Department of Surgery , Saitama Prefecture Cancer Center, Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8600-1199","authenticated-orcid":false,"given":"Hideki","family":"Ueno","sequence":"additional","affiliation":[{"name":"Department of Surgery , National Defense Medical College, Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Katsumata","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal and Pediatric Surgery , Tokyo Medical University, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayoshi","family":"Yasui","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery , Osaka International Cancer Institute, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunsuke","family":"Tsukamoto","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery , National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9735-6630","authenticated-orcid":false,"given":"Hiroshi","family":"Katayama","sequence":"additional","affiliation":[{"name":"Japan Clinical Oncology Group Data Center\/Operations Office , National Cancer Center Hospital, Tokyo, 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, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Shimada","sequence":"additional","affiliation":[{"name":"Clinical Oncology Division , Kochi Health Sciences Center, Kochi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,5,30]]},"reference":[{"key":"2022093018321351400_ref1","doi-asserted-by":"crossref","first-page":"1479","DOI":"10.1016\/S0140-6736(86)91510-2","article-title":"Recurrence and survival after total mesorectal excision for rectal cancer","volume":"1","author":"Heald","year":"1986","journal-title":"Lancet"},{"key":"2022093018321351400_ref2","doi-asserted-by":"crossref","first-page":"616","DOI":"10.1016\/S1470-2045(12)70158-4","article-title":"Postoperative morbidity and mortality after mesorectal excision with and without lateral lymph node dissection for clinical stage II or stage III lower rectal cancer (JCOG0212): results 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Is it regional or distant disease?","volume":"255","author":"Akiyoshi","year":"2012","journal-title":"Ann Surg"},{"key":"2022093018321351400_ref6","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s10147-019-01485-z","article-title":"Japanese society for cancer of the colon and rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer","volume":"25","author":"Hashiguchi","year":"2020","journal-title":"Int J Clin Oncol"},{"key":"2022093018321351400_ref7","first-page":"CD004078","article-title":"Postoperative adjuvant chemotherapy in rectal cancer operated for cure","volume":"2012","author":"Petersen","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"2022093018321351400_ref8","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1007\/s00280-010-1358-1","article-title":"Final results of randomized trials by the National Surgical Adjuvant Study of colorectal cancer 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