A Randomized Phase II/III Trial Comparing Hepatectomy Followed by mFOLFOX6 with Hepatectomy Alone as Treatment for Liver Metastasis from Colorectal Cancer: Japan Clinical Oncology Group Study JCOG0603

被引：56

作者：

Kanemitsu, Yukihide ^{[1
]}

Kato, Tomoyuki ^{[2
]}

Shimizu, Yasuhiro ^{[1
]}

Inaba, Yoshitaka ^{[3
]}

Shimada, Yasuhiro ^{[4
]}

Nakamura, Kenichi ^{[5
]}

Sato, Akihiro ^{[6
]}

Moriya, Yoshihiro ^{[7
]}

机构：

[1] Aichi Canc Ctr Hosp, Dept Surg Gastroenterol, Nagoya, Aichi 464, Japan

[2] Kamiiida Daiichi Gen Hosp, Dept Surg, Nagoya, Aichi, Japan

[3] Aichi Canc Ctr Hosp, Dept Diagnost & Intervent Radiol, Nagoya, Aichi 464, Japan

[4] Natl Canc Ctr, Dept Gastrointestinal, Div Oncol, Tokyo, Japan

[5] Natl Canc Ctr, JCOG Data Ctr, Ctr Canc Control & Informat Serv, Tokyo 104, Japan

[6] Natl Canc Ctr Hosp E, Res Ctr Innovat Oncol, Chiba, Japan

[7] Natl Canc Ctr, Colorectal Surg Div, Tokyo, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2009年 / 39卷 / 06期

关键词：

colorectal cancer; liver metastases; randomized controlled trial; mFOLFOX6; HEPATIC RESECTION; CARCINOMA; SURGERY;

D O I：

10.1093/jjco/hyp035

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

A randomized controlled trial is being conducted in Japan to compare hepatectomy alone with hepatectomy followed by adjuvant chemotherapy as treatment in patients with curatively resected liver metastases from colorectal cancer to improve survival with intensive chemotherapy. Between 42 and 70 days after liver resection, patients are randomly assigned to either hepatectomy alone or hepatectomy followed by 12 cycles of modified FOLFOX6 (mFOLFOX6) regimen. A total of 300 patients (including 78 patients in Phase II) will be accrued from 38 institutions within 3 years. The primary endpoint is treatment compliance at nine courses of mFOLFOX6 regimen in Phase II and disease-free survival in Phase III. The secondary endpoints are overall survival, incidence of adverse events and patterns of recurrence.

引用

页码：406 / 409

页数：4

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