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Kozo Kataoka, Hiroya Takeuchi, Junki Mizusawa, Masahiko Ando, Yasuhiro Tsubosa, Kazuo Koyanagi, Hiroyuki Daiko, Satoru Matsuda, Kenichi Nakamura, Ken Kato, Yuko Kitagawa, on behalf of the Japan Esophageal Oncology Group/Japan Clinical Oncology Group, A randomized Phase III trial of thoracoscopic versus open esophagectomy for thoracic esophageal cancer: Japan Clinical Oncology Group Study JCOG1409, Japanese Journal of Clinical Oncology, Volume 46, Issue 2, February 2016, Pages 174–177, https://doi.org/10.1093/jjco/hyv178
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Abstract
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.