Neoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial

In Japan, esophagectomy after two courses of 5-fluorouracil plus cisplatin is regarded a standard strategy for treating resectable stage II or III esophageal squamous cell carcinoma (ESCC). However, 5-fluorouracil plus cisplatin does not benefit cohorts with clinical stage III ESCC, suggesting the r...

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Autores principales:	Mitsuro Kanda, Dai Shimizu, Kazushi Miyata, Osamu Maeda, Chie Tanaka, Yoshikuni Inokawa, Norofumi Hattori, Masamichi Hayashi, Masahiko Ando, Yachiyo Kuwatsuka, Kenta Murotani, Goro Nakayama, Masahiko Koike, Yuichi Ando, Tomoki Ebata, Yasuhiro Kodera
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Esophageal cancer Squamous cell carcinoma Neoadjuvant chemotherapy S-1 Clinical trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/60bd584ed5604ef4b37d38428dccd043
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spelling	oai:doaj.org-article:60bd584ed5604ef4b37d38428dccd0432021-11-12T04:42:59ZNeoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial2451-865410.1016/j.conctc.2021.100853https://doaj.org/article/60bd584ed5604ef4b37d38428dccd0432021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001538https://doaj.org/toc/2451-8654In Japan, esophagectomy after two courses of 5-fluorouracil plus cisplatin is regarded a standard strategy for treating resectable stage II or III esophageal squamous cell carcinoma (ESCC). However, 5-fluorouracil plus cisplatin does not benefit cohorts with clinical stage III ESCC, suggesting the requirement for a more effective regimen. We are conducting a single-arm phase II study to assess the safety and efficacy of neoadjuvant docetaxel, oxaliplatin plus S-1 (DOS) for treating patients with clinical stage III ESCC. The primary endpoint is the pathological response rate, and the target number is 45 patients. Safety, response rate, R0 resection rate, and survival are secondary endpoints. This trial is registered in the Japan Registry of Clinical Trials as jRCTs041210023. We are conducting a prospective phase II trial to evaluate the safety and efficacy of three courses of neoadjuvant DOS treatment followed by radical esophagectomy for clinical stage III ESCC.Mitsuro KandaDai ShimizuKazushi MiyataOsamu MaedaChie TanakaYoshikuni InokawaNorofumi HattoriMasamichi HayashiMasahiko AndoYachiyo KuwatsukaKenta MurotaniGoro NakayamaMasahiko KoikeYuichi AndoTomoki EbataYasuhiro KoderaElsevierarticleEsophageal cancerSquamous cell carcinomaNeoadjuvant chemotherapyS-1Clinical trialMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100853- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Esophageal cancer Squamous cell carcinoma Neoadjuvant chemotherapy S-1 Clinical trial Medicine (General) R5-920
spellingShingle	Esophageal cancer Squamous cell carcinoma Neoadjuvant chemotherapy S-1 Clinical trial Medicine (General) R5-920 Mitsuro Kanda Dai Shimizu Kazushi Miyata Osamu Maeda Chie Tanaka Yoshikuni Inokawa Norofumi Hattori Masamichi Hayashi Masahiko Ando Yachiyo Kuwatsuka Kenta Murotani Goro Nakayama Masahiko Koike Yuichi Ando Tomoki Ebata Yasuhiro Kodera Neoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial
description	In Japan, esophagectomy after two courses of 5-fluorouracil plus cisplatin is regarded a standard strategy for treating resectable stage II or III esophageal squamous cell carcinoma (ESCC). However, 5-fluorouracil plus cisplatin does not benefit cohorts with clinical stage III ESCC, suggesting the requirement for a more effective regimen. We are conducting a single-arm phase II study to assess the safety and efficacy of neoadjuvant docetaxel, oxaliplatin plus S-1 (DOS) for treating patients with clinical stage III ESCC. The primary endpoint is the pathological response rate, and the target number is 45 patients. Safety, response rate, R0 resection rate, and survival are secondary endpoints. This trial is registered in the Japan Registry of Clinical Trials as jRCTs041210023. We are conducting a prospective phase II trial to evaluate the safety and efficacy of three courses of neoadjuvant DOS treatment followed by radical esophagectomy for clinical stage III ESCC.
format	article
author	Mitsuro Kanda Dai Shimizu Kazushi Miyata Osamu Maeda Chie Tanaka Yoshikuni Inokawa Norofumi Hattori Masamichi Hayashi Masahiko Ando Yachiyo Kuwatsuka Kenta Murotani Goro Nakayama Masahiko Koike Yuichi Ando Tomoki Ebata Yasuhiro Kodera
author_facet	Mitsuro Kanda Dai Shimizu Kazushi Miyata Osamu Maeda Chie Tanaka Yoshikuni Inokawa Norofumi Hattori Masamichi Hayashi Masahiko Ando Yachiyo Kuwatsuka Kenta Murotani Goro Nakayama Masahiko Koike Yuichi Ando Tomoki Ebata Yasuhiro Kodera
author_sort	Mitsuro Kanda
title	Neoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial
title_short	Neoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial
title_full	Neoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial
title_fullStr	Neoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial
title_full_unstemmed	Neoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial
title_sort	neoadjuvant docetaxel, oxaliplatin plus s-1 for treating clinical stage iii squamous cell carcinoma of the esophagus: study protocol of an open-label phase ii trial
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/60bd584ed5604ef4b37d38428dccd043
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Neoadjuvant docetaxel, oxaliplatin plus S-1 for treating clinical stage III squamous cell carcinoma of the esophagus: Study protocol of an open-label phase II trial

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