This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
432
Hepatic Artery Infusion for four cycles: Floxuridine (FUDR) 500mg/d, Day 1-2; DXM 1mg/day added to FUDR 2-day infusion; Heparin 1000U/day added to FUDR 2-day infusion In combination with Systemic Chemotherapy CapeOX for 8 cycles: Oxaliplatin 130 mg/m\^2 iv over 2 hours, Day 1. Capecitabine 850mg/m\^2/d PO Bid, given in the morning and evening, Day 1-14 Or in combination with Systemic Chemotherapy mFOLFOX6 for 12 cycles: Oxaliplatin 85mg/m\^2 IV over 2 hours, Day 1. Leucovorin 400mg/m\^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m\^2 IV and then 2400mg/m\^2 over 48 hours IV continuous infusion. Day 1
Systemic Chemotherapy CapeOX alone for 8 cycles: Oxaliplatin 130 mg/m\^2 iv over 2 hours, Day 1. Capecitabine 850mg/m\^2/d PO Bid, given in the morning and evening, Day 1-14 Or Systemic Chemotherapy mFOLFOX6 alone for 12 cycles: Oxaliplatin 85mg/m\^2 IV over 2 hours, Day 1. Leucovorin 400mg/m\^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m\^2 IV and then 2400mg/m\^2 over 48 hours IV continuous infusion. Day 1
Fudan University Shanghai Cancer Center China
Shanghai, Shanghai Municipality, China
Overall Survival
Overall survival will be measured from the date of randomization up to the date of death of any cause
Time frame: 5-year
Liver Relapse-Free Survival Rate
Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first.
Time frame: 3-year
Disease free survival
DFS is defined as the time interval from the date of randomization to the time of the first relapse at any site, death from any cause, or last recorded follow-up visit.
Time frame: 3-year
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