Developing appropriate therapy for colorectal cancer is one of the most important health issues worldwide. The CORRECT study was a Phase III, international, placebo-controlled study in which the case data was accumulated from 17 countries including Japan. The results showed the overall survival (OS), the primary endpoint, was significantly prolonged in the regorafenib group, compared with the placebo group. A total of 760 patients were enrolled in the CORRECT study, including 100 Japanese patients. On the other hand, the administration method of regorafenib does not depend on the height, weight, or race of the patients, or other parameters, and 160 mg/body/day is the standard starting dose, but some cases require dose reduction to 120 mg/day or less due to the difficulty of continuous administration of 160 mg/day because of adverse events.
This is a multicenter, single-arm, phase II trial. Eligibility criteria include age > = 20 years, histopathologically diagnosed colorectal cancer considered as unresectable due to distant metastasis or locally advanced cancer, indicating disease progression during the standard chemotherapy or within three months after the last administration of the standard chemotherapy, with adequate bone marrow reserve and organ function. The standard chemotherapy includes fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab, and anti-EGFR (incase of patients with only RAS WT). Treatment history of TAS-102 is not allowed. Regorafenib 120 mg/body/day is orally administrated once a day, after meal for 3 weeks (Days 1 to 21), followed by a 1-week treatment-off period (Days 22 to 28). This 4-week period is considered as 1 cycle and shall be repeated until progression of disease based on RECIST v1.1. The purpose of the study is to evaluate the efficacy and safety of regorafenib when starting regorafenib treatment at 120 mg/day for the patients with metastatic colorectal cancer. Primary endpoint: disease control rate ( > = 6 weeks). Secondary endpoints: OS, progression-free survival, response rate, safety, and drug adherence.
Clinical trial identification
Legal entity responsible for the study
Bayer Yakuhin, Ltd., Japan.
T. Kudo: I belong to a donated fund laboratory from Yakult Honsha Co., Ltd., Chugai Pharmaceutical Co., Ltd., and Ono Pharmaceutical Co., Ltd. T. Satoh: Honoraria and consulting fee from: Eli Lilly, Chugai, Merck Serono. Research funding (to institution) from: Sanofi, Yakult Honsha, Chugai, Ono. All other authors have declared no conflicts of interest.