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 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).
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Kozo
authors: K
authors: Kataoka
authors: Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka t.tsushima@scchr.jp.
authors: Takahiro
authors: T
authors: Tsushima
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Junki
authors: J
authors: Mizusawa
authors: Clinical Trial Promotion Department, Chiba Cancer Center, Chiba.
authors: Shuichi
authors: S
authors: Hironaka
authors: Division of Esophageal Surgery, Shizuoka Cancer Center, Shizuoka.
authors: Yasuhiro
authors: Y
authors: Tsubosa
authors: Cancer Chemotherapy Center, Osaka Medical College, Osaka.
authors: Takayuki
authors: T
authors: Kii
authors: Department of Gastroenterological Surgery, Kochi Health Sciences Center, Kochi.
authors: Yuichi
authors: Y
authors: Shibuya
authors: Department of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo.
authors: Keisho
authors: K
authors: Chin
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Hiroshi
authors: H
authors: Katayama
authors: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo.
authors: Ken
authors: K
authors: Kato
authors: JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
authors: Haruhiko
authors: H
authors: Fukuda
authors: Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
authors: Yuko
authors: Y
authors: Kitagawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007564:Japan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D018579:Patient Selection; D012107:Research Design; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: 2-weekly DCF; Phase III; metastatic or recurrent esophageal cancer