This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.
Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in China. Since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Disease control rate
Time frame: Up to 24 weeks
Progression free survival
Time frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
Time frame: From the date of first drug administration until the date of death, assessed up to 60 months
Number of participants with AEs and SAEs as a measure of Safety
Safety data will be assessed at each study visit using NCI CTCAE version 3.0
Time frame: Each follow up visit, assessed up to 24 weeks
EORTC QLQ-C30
Quality of life will be assessed at each study using EORTC QLQ-C30
Time frame: Each follow up visit, assessed up to 24 weeks
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