A randomized phase II study to compare the efficacy and safety of SLOG or mFOLFIRINOX as a first-line treatment for patients with locally advanced and metastatic pancreatic cancer.
A total 130 patients (65 patients per arm) with locally advanced or metastatic pancreatic cancer will be enrolled in multiple hospitals of Taiwan. The primary endpoint is progression-free survival. The secondary endpoints are objective response rate, overall survival and safety profiles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Intervention is administered to patients in this Arm.
Intervention is administered to patients in this Arm.
Intervention is administered to patients in this Arm.
National Institute of Cancer Research
Miaoli, Taiwan
progression free survival (PFS)
The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)
Time frame: Since this is an exploratory trial, it takes a sample size of 61 patients per arm entered in 2 years with a minimum 1 year of follow up to reach 75% power with type I error of 10% under the assumptions of exponential survival functions.
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Intervention is administered to patients in this Arm.
Intervention is administered to patients in this Arm.
Intervention is administered to patients in this Arm.
Intervention is administered to patients in this Arm.