A multicenter,open,prospective randomized controlled trial;11 study center in China; Plan to enroll 328 patients( Power Analysis and Sample Size ).Comparing FOLFIRI with mFOLFOX6,Superiority design.Investigate difference PFS,ORR,R0 resection rate,OS ,QoL and Safety from two regimens Stratification factors : Analyzing patients recurrence within 6-12months,and 12-18months .Obtain definite chemotherapy regimen shift opportunity for patients recurrence/metastasis after adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
328
FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy
SAHZU
Hangzhou, Zhejinag, China
RECRUITINGORR(objective response rate)
imaging evaluation
Time frame: At the end of Cycle 3(6 weeks after first chemotherapy)
PFS
imaging evaluation PD
Time frame: At the end of Cycle 6(each cycle is 14 days)
OS
patient death
Time frame: At the end of Cycle 12(each cycle is 14 days)
R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate
sugery
Time frame: At the end of Cycle 12(each cycle is 14 days)
QoL(quality of life)
Life state
Time frame: At the end of Cycle 12
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