SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or 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.

Inclusion criteria

• Patients must have cyto-/histologically confirmed, locally advanced unresectable or metastatic adenocarcinoma of the pancreas (mPAC). Patients who have disease measurable or evaluable on x-ray, CT scan, or physical examination are eligible.
• Patients must have no history of prior chemotherapy for PAC, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.
• Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease.
• Patients' baseline ECOG performance status must be 1.
• Patients' life expectancy 12 weeks or greater.
• Patients' age 20 and 80.
• Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible.
• Patients must agree to have indwelling venous catheter implanted.
• Women or men and their partners of reproductive potential should agree to use an effective contraceptive method.
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Exclusion criteria

• Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy.
• Patients with central nervous system metastasis
• Patients with active infection
• Pregnant or breast-nursing women
• Patients with active cardiopulmonary disease or history of ischemic heart disease
• Patients who have peripheral neuropathy > Grade I of any etiology
• Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
• Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment
• Patients who are under biologic treatment for their malignancy
• Laboratory tests (hematology, chemistry) outside specified limits:

• WBC ≤ 3 x 10³/mm³
• ANC ≤ 1.5 x 10³/mm³
• Platelets ≤ 100.000/mm³
• Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
• GFR < 60 mL/min
• AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
• Total bilirubin > 2 x ULN
• Albumin < 2.5 g/dL