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

Abstract

e15002 Background: The safety and efficacy of intraoperative chemotherapy in colorectal cancer have not yet been extensively investigated. This randomized control trial was designed to compare the safety and efficacy of intraoperative chemotherapy in combination with surgical resection to those of traditional surgical resection alone. Patients and Methods: From January 2011 to January 2016, 696 colorectal cancer patients were enrolled in this study: 341 patients were randomly assigned to the intraoperative plus surgery group to receive intraoperative chemotherapy (portal vein, intraluminal, and intraperitoneal chemotherapy plus surgical resection), whereas 344 patients were randomized to the control group to undergo surgery alone. Eleven patients withdrew consent. Surgical complications and side effects of intraoperative chemotherapy were compared between the two groups. Results: Intraoperative chemotherapy did not increase the rate of surgical complications, and no severe chemotherapy-associated side effects were observed. There were no significant differences in the length of hospital stay (8.31 vs. 7.98 days, P = 0.138), length of surgery (170.4 vs. 167.0 min, P = 0.526), length of antibiotic use (2.28 vs. 2.15 days, P = 0.322), or length of drain usage (6.37 vs. 6.16 days, P = 0.387) between the intraoperative chemotherapy and control groups. Four patients in each of the intraoperative chemotherapy and the control groups experienced anastomotic leakage and underwent a second operation (1.2% vs. 1.2%, P = 0.99). There were no deaths within 90 days after surgery in the chemotherapy group, whereas one patient died in the control group (0% vs. 0.3%, P = 0.99). Intraoperative chemotherapy did not decrease the rate of patients who received postoperative adjuvant chemotherapy between the intraoperative group and control group (29.3% vs. 30.2%, P = 0.795). Conclusions: Intraoperative chemotherapy can be safely performed during colorectal surgery; however, follow-up is necessary for a better assessment of its efficacy. Register Number: NCT01465451. Clinical trial information: NCT01465451.