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)

Kozo Kataoka; Takahiro Tsushima; Junki Mizusawa; Shuichi Hironaka; Yasuhiro Tsubosa; Takayuki Kii; Yuichi Shibuya; Keisho Chin; Hiroshi Katayama; Ken Kato; Haruhiko Fukuda; Yuko Kitagawa; Japan Esophageal Oncology Group/Japan Clinical Oncology Group

doi:10.1093/jjco/hyv012

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)

Jpn J Clin Oncol. 2015 May;45(5):494-8. doi: 10.1093/jjco/hyv012. Epub 2015 Feb 2.

Affiliations

¹ JCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo.
² Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka [email protected].
³ Clinical Trial Promotion Department, Chiba Cancer Center, Chiba.
⁴ Division of Esophageal Surgery, Shizuoka Cancer Center, Shizuoka.
⁵ Cancer Chemotherapy Center, Osaka Medical College, Osaka.
⁶ Department of Gastroenterological Surgery, Kochi Health Sciences Center, Kochi.
⁷ Department of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo.
⁸ Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo.
⁹ Department of Surgery, Keio University School of Medicine, Tokyo, Japan.

PMID: 25646357
DOI: 10.1093/jjco/hyv012

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).

Keywords: 2-weekly DCF; Phase III; metastatic or recurrent esophageal cancer.

Publication types

Clinical Trial, Phase III
Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Cisplatin / administration & dosage
Disease-Free Survival
Docetaxel
Drug Administration Schedule
Esophageal Neoplasms / drug therapy*
Esophageal Neoplasms / pathology*
Female
Fluorouracil / administration & dosage
Humans
Japan
Middle Aged
Neoplasm Recurrence, Local / drug therapy*
Patient Selection
Research Design
Survival Analysis
Taxoids / administration & dosage
Treatment Outcome

Substances

Taxoids
Docetaxel
Cisplatin
Fluorouracil