期刊
CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS
卷 24, 期 -, 页码 -出版社
ELSEVIER INC
DOI: 10.1016/j.conctc.2021.100853
关键词
Esophageal cancer; Squamous cell carcinoma; Neoadjuvant chemotherapy; S-1; Clinical trial
资金
- Nagoya University Hospital Funding for Clinical Development
This study aims to assess the safety and efficacy of neoadjuvant docetaxel, oxaliplatin, and S-1 combination therapy for patients with clinical stage III esophageal squamous cell carcinoma.
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.
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