The study is a randomized,multicenter, double-blinded,phase III study. To explore the affection of vitamin D3 in combination with oxaliplatin plus fluoropyrimidine versus oxaliplatin plus fluoropyrimidine as first-line chemotherapy in previously untreated advanced or metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
750
vitamin D3 400IU\*5pills po. qd continue to disease progression
placebo 5 pills po. qd continue to disease progression
PFS(progression-free survival)
PFS is defined the time from the date of randomization to the date of disease progression or death due to any cause.
Time frame: 5 years
OS(overall survival)
OS is defined the time between the date of randomization and the date of death.
Time frame: 5 years
DCR
disease control rate
Time frame: up to 1 year
ORR
overall response rate
Time frame: up to 1 year
Incidence of Treatment-Emergent Adverse Events
all the adverse events
Time frame: through study completion, an average of 1 year
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