{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T20:54:26Z","timestamp":1789419266194,"version":"build-2803163510"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2023,11,1]],"date-time":"2023-11-01T00:00:00Z","timestamp":1698796800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Cancer Centre Research and Development Fund"},{"DOI":"10.13039\/100009619","name":"AMED","doi-asserted-by":"publisher","award":["JP23ck0106836"],"award-info":[{"award-number":["JP23ck0106836"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Radical surgery is the standard treatment for rectal cancer, but can impact quality of life. Recently, the concept of total neoadjuvant therapy with a watch-and-wait strategy has been proposed in which patients with a cCR after total neoadjuvant therapy do not proceed to surgery. However, most investigations of a watch-and-wait strategy have reported cases where cCR was achieved coincidentally via total neoadjuvant therapy. The aim is to assess whether total neoadjuvant therapy is effective in early-stage rectal cancer in patients that achieve cCR and are offered a watch-and-wait strategy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>JCOG2010 (TOWARd) is a multi-institutional, single-arm phase II\/III confirmatory investigation of the safety and efficacy of total neoadjuvant therapy followed by a watch-and-wait strategy for rectal cancer. Key eligibility criteria include cT2\u20133 N0 M0 rectal adenocarcinoma, tumour diameter less than or equal to 5\u2005cm, age 18\u201375 years, performance status 0\u20131, and no history of pelvic irradiation or rectal surgery. Total neoadjuvant therapy involves neoadjuvant chemoradiotherapy (capecitabine and radiotherapy: 45\u2005Gy\/25 fractions to the whole pelvis plus boost of 5.4\u2005Gy\/3 fractions to the primary tumour) followed by consolidation chemotherapy (four cycles of capecitabine\/oxaliplatin). Patients will be re-staged every 8 weeks after total neoadjuvant therapy, and those who achieve cCR will undergo a watch-and-wait strategy, those with near complete response will undergo a watch-and-wait strategy or local resection, and those with an incomplete response will undergo radical surgery. The primary endpoint is the cCR rate in phase II and 5-year overall survival in phase III. Secondary endpoints include postoperative anal, urinary, and sexual function. A total of 105 patients (phase II, 40 patients; phase III, 65 patients) will be enrolled over 3.5 years.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>This trial will determine whether total neoadjuvant therapy and a watch-and-wait strategy is an effective alternative to radical surgery for early-stage rectal cancer in patients with cT2\u20133 N0 M0 and tumour size less than or equal to 5\u2005cm.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Registration number<\/jats:title>\n                  <jats:p>jRCTs031220288 (https:\/\/jrct.niph.go.jp\/en-latest-detail\/jRCTs031220288).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjsopen\/zrad110","type":"journal-article","created":{"date-parts":[[2023,11,6]],"date-time":"2023-11-06T20:39:42Z","timestamp":1699303182000},"source":"Crossref","is-referenced-by-count":12,"title":["Total neoadjuvant therapy followed by a watch-and-wait strategy for patients with rectal cancer (TOWARd): protocol for single-arm phase II\/III confirmatory trial (JCOG2010)"],"prefix":"10.1093","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3759-1214","authenticated-orcid":false,"given":"Tadayoshi","family":"Hashimoto","sequence":"first","affiliation":[{"name":"Japan Clinical Oncology Group Data Centre\/Operations Office, National Cancer Centre Hospital , Tokyo , Japan"},{"name":"Translational Research Support Section, National Cancer Centre Hospital East , Kashiwa , Japan"},{"name":"Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Centre Hospital East , Kashiwa , 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