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- Title
A randomized controlled Phase III trial comparing 2-weekly docetaxel combined with cisplatin plus fluorouracil (2-weekly DCF) with cisplatin plus fluorouracil (CF) in patients with metastatic or recurrent esophageal cancer: rationale, design and methods of Japan Clinical Oncology Group study JCOG1314 (MIRACLE study).
- Authors
Kozo Kataoka; Takahiro Tsushima; Junki Mizusawa; Shuichi Hironaka; Yasuhiro Tsubosa; Takayuki Kii; Yuichi Shibuya; Keisho Chin; Hiroshi Katayama; Ken Kato; Haruhiko Fukuda; Yuko Kitagawa
- Abstract
Chemotherapy with cisplatin plus fluorouracil is the current standard treatment for metastatic or recurrent esophageal cancer. We have developed a 2-weekly docetaxel combined with CF regimen and conducted a Phase I/II trial for metastatic or recurrent esophageal cancer (JCOG0807). Promising efficacy and safety were shown in JCOG0807, and we have commenced a Phase III trial in September 2014 to confirm the superiority of 2-weekly DCF to CF for patients with metastatic or recurrent esophageal cancer. Atotal of 240 patients will be accrued from 41 Japanese institutions overa period of 4 years. The primary end point is overall survival. The secondary end points are progression-free survival, response rate and proportion of adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000015107 (http://www.umin.ac.jp/ctr/index.htm).
- Publication
Japanese Journal of Clinical Oncology, 2015, Vol 45, Issue 5, p494
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyv012