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

共 40 条

[21] Randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor: Japan clinical oncology group study JCOG 0705 and korea gastric cancer association study KGCA01 [J].

Fujitani, Kazumasa ;

Yang, Han-Kwang ;

Kurokawa, Yukinori ;

Park, Do Joong ;

Tsujinaka, Toshimasa ;

Park, Byung-Joo ;

Fukuda, Haruhiko ;

Noh, Sung Hoon ;

Boku, Narikazu ;

Bang, Yung-Jue ;

Sasako, Mitsuru ;

Lee, Jong-Inn .

JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2008, 38 (07) :504-506

[22] Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404) [J].

Saito, Shuji ;

Akagi, Tomonori ;

Katayama, Hiroshi ;

Wakabayashi, Masashi ;

Inomata, Masafumi ;

Yamamoto, Seiichiro ;

Ito, Masaaki ;

Kinugasa, Yusuke ;

Egi, Hiroyuki ;

Munakata, Yasuhiro ;

Kokuba, Yukihito ;

Bando, Hiroyuki ;

Yasui, Masayoshi ;

Ikeda, Masataka ;

Nakajima, Kentaro ;

Shida, Dai ;

Kanemitsu, Yukihide ;

Kitano, Seigo .

ANNALS OF GASTROENTEROLOGICAL SURGERY, 2021, 5 (06) :804-812

[23] Male sexual dysfunction after rectal cancer surgery: Results of a randomized trial comparing mesorectal excision with and without lateral lymph node dissection for patients with lower rectal cancer: Japan Clinical Oncology Group Study JCOG0212 [J].

Saito, S. ;

Fujita, S. ;

Mizusawa, J. ;

Kanemitsu, Y. ;

Saito, N. ;

Kinugasa, Y. ;

Akazai, Y. ;

Ota, M. ;

Ohue, M. ;

Komori, K. ;

Shiozawa, M. ;

Yamaguchi, T. ;

Akasu, T. ;

Moriya, Y. .

EJSO, 2016, 42 (12) :1851-1858

[24] Study protocol: randomized phase III trial of neo-adjuvant and adjuvant chemotherapy vs. immediate surgery and adjuvant chemotherapy for localized soft tissue sarcoma: Japan Clinical Oncology Group study JCOG2102 (NACLESS) [J].

Funauchi, Yuki ;

Tsukushi, Satoshi ;

Hiraga, Hiroaki ;

Sakamoto, Akio ;

Kunisada, Toshiyuki ;

Nagano, Akihito ;

Hiraoka, Koji ;

Kikuta, Kazutaka ;

Yonemoto, Tsukasa ;

Ae, Keisuke ;

Kawai, Akira ;

Endo, Makoto ;

Sano, Yusuke ;

Machida, Ryunosuke ;

Sekita, Tetsuya ;

Fukuda, Haruhiko ;

Oda, Yoshinao ;

Ozaki, Toshifumi ;

Tanaka, Kazuhiro .

JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2024, 55 (03) :297-303

[25] Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104) [J].

Takeda, K. ;

Negoro, S. ;

Tamura, T. ;

Nishiwaki, Y. ;

Kudoh, S. ;

Yokota, S. ;

Matsui, K. ;

Semba, H. ;

Nakagawa, K. ;

Takada, Y. ;

Ando, M. ;

Shibata, T. ;

Saijo, N. .

ANNALS OF ONCOLOGY, 2009, 20 (05) :835-841

[26] Feasibility Assessment of Modified FOLFOX-6 as Adjuvant Treatment after Resection of Liver Metastases from Colorectal Cancer: Analyses of a Multicenter Phase II Clinical Trial (MiyagiHBPCOG Trial-001) [J].

Katayose, Yu ;

Yamamoto, Kuniharu ;

Nakagawa, Kei ;

Takemura, Shinichi ;

Takahashi, Michinaga ;

Nakamura, Ryuji ;

Shimamura, Hiromune ;

Rikiyama, Toshiki ;

Egawa, Shinichi ;

Yoshda, Hiroshi ;

Motoi, Fuyuhiko ;

Naitoh, Takeshi ;

Unno, Michiaki .

HEPATO-GASTROENTEROLOGY, 2015, 62 (138) :303-308

[27] Phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy to pelvic lymphadenectomy alone for endometrial cancer: Japan Clinical Oncology Group Study 1412 (SEPAL-P3) [J].

Watari, Hidemichi ;

Katayama, Hiroshi ;

Shibata, Taro ;

Ushijima, Kimio ;

Satoh, Toyomi ;

Onda, Takashi ;

Aoki, Daisuke ;

Fukuda, Haruhiko ;

Yaegashi, Nobuo ;

Sakuragi, Noriaki .

JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2017, 47 (10) :986-990

[28] 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) [J].

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

[29] Mature Results of a Prospective Randomized Trial Comparing 5-Flourouracil with Leucovorin to 5-Flourouracil with Levamisole as Adjuvant Therapy of Stage II and III Colorectal Cancer-The Israel Cooperative Oncology Group (ICOG) Study [J].

Figer, Arie ;

Nissan, Aviram ;

Shani, Adi ;

Borovick, Riva ;

Stiener, Mariana ;

Baras, Mario ;

Freund, Herbert R. ;

Sulkes, Aaron ;

Stojadinovic, Alexander ;

Peretz, Tamar .

JOURNAL OF CANCER, 2011, 2 :177-185

[30] A randomized phase II/III trial of conventional paclitaxel and carboplatin with or without bevacizumab vs dose-dense paclitaxel and carboplatin with or without bevacizumab, in stage IVB, recurrent or persistent cervical carcinoma: Japan Clinical Oncology Group Study (JCOG1311) [J].

Ishikawa, Mitsuya ;

Nakamura, Kenichi ;

Shibata, Taro ;

Tanaka, Kiyo ;

Kitagawa, Ryo ;

Kobayashi, Hiroaki ;

Yaegashi, Nobuo .

JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2018, 48 (12) :1096-1100

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