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Poster Display session 2

3059 - Intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection (IOCCRC): A randomized, multicenter, prospective, phase III trial


29 Sep 2019


Poster Display session 2


Tumour Site

Colon and Rectal Cancer


Rongxin Zhang


Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246


R. Zhang1, X. Wu1, D. Wan1, J. Lin1, P. Ding1, J. Lei2, Z. Lu1, L. Li1, G. Chen1, L. Kong1, F. Wang1, D. Zhang3, W. Fan1, W. Jiang1, W. Zhou1, C. Li1, Y. Li1, X. Li1, Z. Pan1

Author affiliations

  • 1 Colorectal Department, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 2 Department Of General Surgery, The First A liated Hospital of Guangzhou Medical University, 510060 - Guangzhou/CN
  • 3 Department Of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, 19104 - Philadelphia/US


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Abstract 3059


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.


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%.


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 (< 5ng/ml) still did not benefit from intraoperative chemotherapy (p = 0.298).


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


Editorial acknowledgement

Legal entity responsible for the study

Zhizhong Pan.


Sun Yat-sen University 5010 funding.


All authors have declared no conflicts of interest.

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