The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. The patients will be treated with systemic FOLFOXIRI chemotherapy or FUDR/Oxaliplatin hepatic arterial infusion with CPT-11 systemic chemotherapy.
Previous studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. Hepatic arterial infusion oxaliplatin trials have been done with oxaliplatin alone and in combination with irinotecan, 5-FU/LV, and mitomycin-C and have showed that Hepatic arterial infusion oxaliplatin and FUDR could increase response rate and resection rate for colorectal liver metastasis. Therefore, we designed this study to compare objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and 15.
Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.
0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Overall Response Rate and bilateral 95% confidence interval
defined as complete remission rates and partial remission rates after treatment.
Time frame: Up to 2-4 months
R0 resection rates
defined as no macroscopic or microscopic residual tumor
Time frame: Up to 2-4 months
Depth of tumor regression(DpR)
defined as the largest depth of tumor regression
Time frame: Up to 2-4 months
Progress-free Survival(PFS)
defined as the period from the date of receiving treatment to disease progress caused by any reason.
Time frame: Up to 2-4 months
Relapse-free Survival(RFS) of patients with resectable tumor
defined as the period from the date of resection to tumor relapse caused by any reason.
Time frame: Up to 2-4 months
Overall Survival(OS)
defined as the period from the date of receiving treatment to death caused by any reason.
Time frame: Up to 2-4 months
Adverse events, servere adverse events and surgery-related adverse events rates
defined as the incidence and severity of adverse events related to chemotherapy, HAI and surgery.
Time frame: Up to 2-4 months
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Leucovorin 200mg/m2 IV on Day 1 and 15.
5-FU 2400mg/m2 CIV in 46h on Day 1 and 15.
Oxaliplatin 85 mg/m2 IV over 3 hours on Day1 and 15.