Kanda Mitsuro, Shimizu Dai, Miyata Kazushi, Maeda Osamu, Tanaka Chie, Inokawa Yoshikuni, Hattori Norofumi, Hayashi Masamichi, Ando Masahiko, Kuwatsuka Yachiyo, Murotani Kenta, Nakayama Goro, Koike Masahiko, Ando Yuichi, Ebata Tomoki, Kodera Yasuhiro
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
Contemp Clin Trials Commun. 2021 Nov 9;24:100853. doi: 10.1016/j.conctc.2021.100853. eCollection 2021 Dec.
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.
在日本，对于可切除的II期或III期食管鳞状细胞癌（ESCC），采用两疗程5-氟尿嘧啶加顺铂治疗后进行食管切除术被视为标准治疗策略。然而，5-氟尿嘧啶加顺铂对临床III期ESCC患者并无益处，这表明需要一种更有效的治疗方案。我们正在开展一项单臂II期研究，以评估新辅助多西他赛、奥沙利铂加S-1（DOS）治疗临床III期ESCC患者的安全性和疗效。主要终点是病理缓解率，目标病例数为45例患者。安全性、缓解率、R0切除率和生存率为次要终点。该试验已在日本临床试验注册中心注册，注册号为jRCTs041210023。我们正在进行一项前瞻性II期试验，以评估三疗程新辅助DOS治疗后行根治性食管切除术治疗临床III期ESCC的安全性和疗效。
