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Intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection (IOCCRC): A randomized, multicenter, prospective, phase III trial

Abstract Background Whether colorectal cancer patients who undergo radical resection can benefit from intraoperative chemotherapy is still under debate. Therefore, we aimed to compare the results of intraoperative chemotherapy combined with radical surgical resection with surgical resection alone in colorectal cancer patients. Methods This is a multicenter, open-label, randomized, non-inferiority, phase 3 trial. All patients who had been histologically confirmed and could receive radical resection with no sign of distance metastasis, were enrolled. The patients were randomized to receive intraoperative chemotherapy with radical surgical resection, or radical surgery resection alone (1:1). Intraoperative chemotherapy included portal vein chemotherapy (200 mg/m2 5-FU), intraluminal chemotherapy (1000 mg/m2 5-FU), and intraperitoneal chemotherapy (300mg/m2 5-FU). The primary endpoint was 3-year disease-free survival (DFS) analyzed on an intention-to-treat basis with an α of 0.05 and a power of 80%. Results From January 2011 to January 2016, 685 colorectal cancer patients were enrolled and randomly assigned to intraoperative chemotherapy with radical surgical resection (n = 341), or surgical resection alone (control group, n = 344). After a median follow-up of 65.1 months, 21 patients in the intraoperative chemotherapy group and 26 patients in the control group had died. 39 patients in the intraoperative chemotherapy group and 47 patients in the control group experienced distance metastasis or local recurrence. Intraoperative chemotherapy showed no significant benefit for colorectal cancer patients who underwent radical resection (p = 0.334). Subgroup analyses showed that patients with pre-treatment abnormal CEA level (> 5ng/ml) could benefit from intraoperative chemotherapy (p = 0.026, HR:0.516). The patients with pre-treatment normal CEA level ( Conclusions Intraoperative chemotherapy could improve 3-years DFS of colorectal cancer patients whose pre-treatment serum CEA level was higher than 5ng/ml. Clinical trial identification NCT01465451. Legal entity responsible for the study Zhizhong Pan. Funding Sun Yat-sen University 5010 funding. Disclosure All authors have declared no conflicts of interest.