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)

被引：19

作者：

Kataoka, Kozo ^{[1
]}

Tsushima, Takahiro ^{[2
]}

Mizusawa, Junki ^{[1
]}

Hironaka, Shuichi ^{[3
]}

Tsubosa, Yasuhiro ^{[4
]}

Kii, Takayuki ^{[5
]}

Shibuya, Yuichi ^{[6
]}

Chin, Keisho ^{[7
]}

Katayama, Hiroshi ^{[1
]}

Kato, Ken ^{[8
]}

Fukuda, Haruhiko ^{[1
]}

Kitagawa, Yuko ^{[9
]}

机构：

[1] Natl Canc Ctr, Ctr Res Adm & Support, JCOG Data Ctr, Operat Off, Tokyo 104, Japan

[2] Shizuoka Canc Ctr, Div Gastrointestinal Oncol, Shizuoka, Japan

[3] Chiba Canc Ctr, Clin Trial Promot Dept, Chiba 2608717, Japan

[4] Shizuoka Canc Ctr, Div Esophageal Surg, Shizuoka, Japan

[5] Osaka Med Coll, Canc Chemotherapy Ctr, Osaka, Japan

[6] Kochi Hlth Sci Ctr, Dept Gastroenterol Surg, Kochi, Japan

[7] Japanese Fdn Canc Res, Canc Inst Hosp, Dept Gastroenterol, Tokyo, Japan

[8] Natl Canc Ctr, Gastrointestinal Med Oncol Div, Tokyo, Japan

[9] Keio Univ, Sch Med, Dept Surg, Tokyo 160, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2015年 / 45卷 / 05期

关键词：

metastatic or recurrent esophageal cancer; 2-weekly DCF; Phase III; SQUAMOUS-CELL CARCINOMA; COMBINATION CHEMOTHERAPY; 5-FLUOROURACIL; I/II; 5-FU; HEAD;

D O I：

10.1093/jjco/hyv012

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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).

引用

页码：494 / 498

页数：5

共 31 条

[31] A multi-institutional randomized phase III trial comparing postoperative radiotherapy to observation after adjuvant chemotherapy in patients with pathological N2 Stage III non-small cell lung cancer: Japan Clinical Oncology Group Study JCOG1916 (J-PORT study)
Shimoyama, Ryo
Nakagawa, Kazuo
Ishikura, Satoshi
Wakabayashi, Masashi
Sasaki, Tomonari
Yoshioka, Hiroshige
Hashimoto, Tadayoshi
Kataoka, Tomoko
Fukuda, Haruhiko
Watanabe, Shun-Ichi
JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2021, 51 (06) : 999 - 1003

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