Study protocol of the TRICOLORE trial: a randomized phase III study of oxaliplatin-based chemotherapy versus combination chemotherapy with S-1, irinotecan, and bevacizumab as first-line therapy for metastatic colorectal cancer

BMC Cancer

Study Protocol

Satoshi Morita¹  Yoshito Komatsu²  Chikashi Ishioka³  Shin Takahashi³  Satoshi Yuki⁴  Ken Shimada⁵  Atsushi Sato⁶  Makio Gamoh⁷  Tatsuro Yamaguchi⁸  Yasuhide Yamada⁹  Rei Goto^1,10  Minoru Kurihara^1,11 

[1] Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, 606-8507, Sakyo-ku, Kyoto, Japan;Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Kita-15 Nishi-7 Kita-ku, 060-8638, Sapporo, Japan;Department of Clinical Oncology, Institute of Development, Aging and Cancer, Tohoku University, 4-1 Seiryo-machi, Aoba-ku, 980-8575, Sendai, Japan;Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Kita-15 Nishi-7 Kita-ku, 060-8638, Sapporo, Japan;Department of Internal Medicine, Showa University Kouto Toyosu Hospital, 5-1-38 Toyosu, Kouto-ku, 135-8577, Tokyo, Japan;Department of Medical Oncology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, 036-8562, Hirosaki, Aomori, Japan;Department of Medical Oncology, Osaki Citizen Hospital, 2-3-10 Senjujicho, 989-6183, Hurukawa, Osaki Miyagi, Japan;Department of Surgery, Tokyo Metropolitan Cancer and Infectious diseases Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, 113-8677, Tokyo, Japan;Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, 104-0045, Tokyo, Japan;Hakubi Center of Advanced Research, Kyoto University, Yoshida-Ushinomiyacho, 606-8501, Sakyo-ku, Kyoto, Japan;Graduate School of Economics, Kyoto University, Yoshida-Honmachi, 606-8501, Sakyo-ku, Kyoto, Japan;The Tokyo Cooperative Oncology Group, 2-1-18 Hamamatsu-cho, Minato-ku, 105-0013, Tokyo, Japan;

关键词: Bevacizumab;    Irinotecan;    Oxaliplatin;    Metastatic Colorectal Cancer;    Comparative Effectiveness Research;   

DOI  :  10.1186/s12885-015-1630-1

 received in 2014-04-22, accepted in 2015-08-27,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundMetastatic colorectal cancer carries a poor prognosis and cannot be cured by currently available therapy. Chemotherapy designed to prolong survival and improve the quality of life (QOL) of patients is the mainstay of treatment. Standard regimens of FOLFOX/bevacizumab and CapeOX/bevacizumab can cause neurotoxicity, potentially disrupting treatment. The results of 3 phase II studies of combination therapy with S-1, irinotecan, and bevacizumab showed comparable efficacy to mFOLFOX6/bevacizumab and CapeOX/bevacizumab, without severe neurotoxicity. Therefore, the establishment and evaluation of S-1-containing irinotecan-based regimens for first-line treatment are expected to become more important.MethodsThe TRICOLORE trial is a multicenter, randomized, open-label, controlled phase III study which aims to evaluate the non-inferiority of combination therapy with S-1/irinotecan/bevacizumab (a 3-week regimen [SIRB] or 4-week regimen [IRIS/bevacizumab]) to oxaliplatin-based standard treatment (mFOLFOX6/bevacizumab or CapeOX/bevacizumab) in patients with metastatic colorectal cancer who had not previously received chemotherapy. Patients will be randomly assigned to either the control group (mFOLFOX6/bevacizumab or CapeOX/bevacizumab) or study group (SIRB or IRIS/bevacizumab). The target sample size is 450 patients. The primary endpoint is progression-free survival (PFS), and the secondary endpoints are overall survival (OS), response rate (RR), time to treatment failure (TTF), relative dose intensity (RDI), the incidence and severity of adverse events, quality of life (QOL), quality-adjusted life years (QALY), health care costs, and relations between biomarkers and treatment response (translational research, TR).DiscussionThe results of this study will provide important information that will help to improve the therapeutic strategy for metastatic colorectal cancer, and we believe that this study is very meaningful from the perspective of comparative effectiveness research.Trial registrationUMIN000007834

【 授权许可】

CC BY   
© Komatsu et al. 2015