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)

作者：Kataoka Kozo; Tsushima Takahiro^*; Mizusawa Junki; Hironaka Shuichi; Tsubosa Yasuhiro; Kii Takayuki; Shibuya Yuichi; Chin Keisho; Katayama Hiroshi; Kato Ken; Fukuda Haruhiko; Kitagawa Yuko

来源：Japanese Journal of Clinical Oncology, 2015, 45(5): 494-498.

DOI：10.1093/jjco/hyv012

• metastatic or recurrent esophageal cancer
• 2-weekly DCF
• Phase III

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 from 41 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. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000015107 (http://www.umin.ac.jp/ctr/index.htm).

• 出版日期2015-5
• 单位中国医学科学院肿瘤医院