A randomized phase II study comparing preoperative mFOLFOX6 versus FOLFOXIRI for locally advanced colon cancer: JCOG2006

被引：1

作者：

Hashimoto, Tadayoshi ^{[1
]}

Maruyama, Satoshi ^{[2
]}

Takii, Yasumasa ^{[2
]}

Mizusawa, Junki ^{[1
]}

Kataoka, Tomoko ^{[1
]}

Fukuda, Haruhiko ^{[1
]}

Tsukamoto, Shunsuke ^{[3
]}

Takashima, Atsuo ^{[4
]}

Hamaguchi, Tetsuya ^{[5
]}

Kanemitsu, Yukihide ^{[3
]}

Colorectal Canc Study Grp, Colorectal Canc Study Grp

Japan Clinical Oncology Grp, Japan Clinical Oncology Grp

机构：

[1] Natl Canc Ctr, Japan Clin Oncol Grp, Operat Off, Data Ctr, Tokyo, Japan

[2] Niigata Canc Ctr Hosp, Dept Surg, Niigata, Japan

[3] Natl Canc Ctr, Dept Colorectal Surg, Tokyo, Japan

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

[5] Saitama Med Univ Int Med Ctr, Dept Gastroenterol Oncol, Hidaka, Japan

来源：

FUTURE ONCOLOGY | 2023年 / 19卷 / 28期

关键词：

colon cancer; FOLFOXIRI; locally advanced; mFOLFOX6; preoperative chemotherapy; selection design; METASTATIC COLORECTAL-CANCER; COMPUTED-TOMOGRAPHY; 1ST-LINE TREATMENT; FLEXIBLE DESIGN; RECTAL-CANCER; OPEN-LABEL; OXALIPLATIN; FOLFIRI; CLASSIFICATION; CHEMOTHERAPY;

D O I：

10.2217/fon-2023-0091

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The prognosis of locally advanced colon cancer (LACC) with surgical resection followed only by adjuvant chemotherapy is poor. Preoperative chemotherapy for LACC patients with risk factors such as cT4bN+ or cT3-4aN2-3 has attracted attention. Here, the authors describe the rationale and design of JCOG2006, a randomized phase II study comparing preoperative chemotherapy with mFOLFOX6 versus FOLFOXIRI for LACC. Their efficacy and safety are evaluated and a determination of which is the more promising treatment will be conducted in a subsequent phase III trial. A total of 86 patients will be accrued from 44 institutions over 2 years. The primary end point is the proportion of patients with a Tumor Regression Score of 0-2, and secondary end points include overall survival, response rate and adverse events.Clinical Trial Registration: jRCTs031210365 (https://jrct.niph.go.jp/) A randomized phase II selection design trial for resectable locally advanced colon cancer to determine whether mFOLFOX6 or FOLFOXIRI is more promising for a subsequent phase III trial.

引用

页码：1897 / 1904

页数：8

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