A randomized Phase III trial of thoracoscopic versus open esophagectomy for thoracic esophageal cancer: Japan Clinical Oncology Group Study JCOG1409

被引：56

作者：

Kataoka, Kozo ^{[1
]}

Takeuchi, Hiroya ^{[2
]}

Mizusawa, Junki ^{[1
]}

Ando, Masahiko ^{[3
]}

Tsubosa, Yasuhiro ^{[4
]}

Koyanagi, Kazuo ^{[5
]}

Daiko, Hiroyuki ^{[6
]}

Matsuda, Satoru ^{[2
]}

Nakamura, Kenichi ^{[1
]}

Kato, Ken ^{[7
]}

Kitagawa, Yuko ^{[2
]}

机构：

[1] Ctr Res Adm & Support, Natl Canc Ctr, Operat Off, JCOG Data Center, Tokyo, Japan

[2] Keio Univ, Sch Med, Dept Surg, Tokyo 160, Japan

[3] Nagoya Univ Hosp, Ctr Adv Med & Clin Res, Nagoya, Aichi, Japan

[4] Shizuoka Canc Ctr, Div Esophageal Surg, Shizuoka, Japan

[5] Natl Canc Ctr, Div Esophageal Surg, Tokyo, Japan

[6] Natl Canc Ctr Hosp East, Div Esophageal Surg, Chiba, Japan

[7] Natl Canc Ctr, Gastrointestinal Med Oncol Div, Tokyo, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2016年 / 46卷 / 02期

关键词：

thoracoscopic esophagectomy; open esophagectomy; Phase III; 3-FIELD LYMPHADENECTOMY; OUTCOMES; TERM;

D O I：

10.1093/jjco/hyv178

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

A randomized Phase III study was commenced in May 2015 to confirm the non-inferiority of thoracoscopic esophagectomy to open esophagectomy in terms of overall survival for clinical Stage I-III esophageal cancer. A total of 300 patients will be accrued from Japanese institutions over 6 years. The primary endpoint is overall survival. The secondary endpoints are relapse-free survival, proportion of patients with R0 resection, proportion of patients who underwent re-operation, adverse events, postoperative respiratory function change, postoperative quality-of-life score (EORTC QLQ-C30), and proportion of patients who need conversion from thoracoscopic surgery to open surgery. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000017628.

引用

页码：174 / 177

页数：4

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