The primary objective of this study is to determine whether systemic chemotherapy combined with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.
Recent 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. However, most of them are retrospective studies, phase I or II clinical researches, which could not provide high-level evidence. Therefore, we designed this study to determine whether systemic chemotherapy combined with HAI can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Patients will receive mFOLFOX6 every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15.
Patients will receive HAI every 28 days: 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. This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGComplete resection rates (R0 resection rates) (defined as no macroscopic or microscopic residual tumor) of both arms
Time frame: Up to 2-4 months
Overall response rates (ORR) of both arms
Time frame: Up to 4-8 monthes
R1 resection rates (with microscopic residual tumor) of both arms
Time frame: Up to 2-4 monthes
Specific R0/R1 resection plus radiofrequency ablation rates of both arms
Time frame: Up to 2-4 monthes
Recurrence-free survival (RFS) of both arms
Time to recurrence or death
Time frame: Up to 5 years
5 year cancer specific survival rate of the whole population
Time frame: Up to 5 years
Progression free survival(PFS) of both arms
Time frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthes
Overall survival (OS) of both arms
Time frame: From the date of first drug administration until the date of death, assessed up to 5 years
Number of participants with surgical complications, AES and SAEs as a measure of safety
Time frame: Each follow up visit, assessed up to 2 years
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