@article{daf92df2e3624601873ce1ee88aa944c,
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)",
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. A total of 240 patients will be accrued from41 Japanese institutions over a 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.",
keywords = "2-weekly DCF, Metastatic or recurrent esophageal cancer, Phase III",
author = "{Japan Clinical Oncology Group} and {Japan Esophageal Oncology Group} and Kozo Kataoka and Takahiro Tsushima and Junki Mizusawa and Shuichi Hironaka and Yasuhiro Tsubosa and Takayuki Kii and Yuichi Shibuya and Keisho Chin and Hiroshi Katayama and Ken Kato and Haruhiko Fukuda and Yuko Kitagawa",
note = "Funding Information: This study is supported by the National Cancer Center Research and Development Fund (26-A-4). Publisher Copyright: {\textcopyright} The Author 2015. Published by Oxford University Press. All rights reserved.",
year = "2015",
month = may,
day = "1",
doi = "10.1093/jjco/hyv012",
language = "English",
volume = "45",
pages = "494--498",
journal = "Japanese Journal of Clinical Oncology",
issn = "0368-2811",
publisher = "Oxford University Press",
number = "5",
}
