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)

Japan Clinical Oncology Group, Japan Esophageal Oncology Group

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)494-498
Number of pages5
JournalJapanese journal of clinical oncology
Volume45
Issue number5
DOIs
Publication statusPublished - 2015 May 1

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Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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