HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.
Numerous retrospective studies have indicated a positive synergistic effect of combining adjuvant oxaliplatin/irinotecan-based doublet systemic chemotherapy and hepatic arterial infusion (HAI) for colorectal cancer (CRC) patients following colorectal cancer liver metastases (CRLM) resection. However, this strategy has not been evaluated prospectively to date. HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Floxuridine(FUDR) 0.12 mg/kg/day,on Day 1-14 through the HAI pump.
Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.
Leucovorin 200mg/m2 ivd over 2 hours on Day 1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
3 Year Relapse Free Survival Rate
Calculated from the time of liver metastasectomy to the time of recurrence or death, whichever came first or censored at the date of the last follow-up for recurrence-free patients that were still alive
Time frame: up to 36 months
Overall Survival
From date of randomization until the date of death from any cause, assessed up to 5 years
Time frame: up to 5 years
Treatment-related adverse events
Number of patients with adverse events and severity measured according to the NCI CTC 3.0 criteria
Time frame: Up to 36 months
Liver-specific RFS
Measure of the time period during which a patient remains free from the recurrence of liver-related events
Time frame: Up to 36 months
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5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
Irinotecan 180mg/m2