mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

This is a phase II study. Patients with resectable pancreatic carcinoma will receive adjuvant chemotherapy of FOLFIRINOX for 6 months.

Primary endpoint is the disease free survival. Secondary endpoints are overall survival, safety and quality of life.

Inclusion criteria

• Histologically confirmed adenocarcinoma of the pancreas without distant metastases.
• Receive radical resection of pancreatic cancer
• No prior cytostatic chemotherapy
• Female and male patients > 18 and <=79 years using contraception
• ECOG ≤ 1
• Patient has adequate bone marrow and organ function
• Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L Platelets ≥ 90 x 109/L Hemoglobin ≥ 90 g/L
• Patient has adequate liver function AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 1.2 x ULN Creatinine ≤ 1.25 times ULN
• Good compliance
• Written informed consent

Exclusion criteria

• Pregnant or lactating women
• Distant metastasis.
• Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
• Refuse to take appropriate contraceptive measures (including male patients).
• Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
• Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
• Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
• Psychiatric illness that would prevent the patient from giving informed consent.
• Patient is concurrently using other antineoplastic agent
• Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
• Known HIV-positivity.
• No history of chronic diarrhea, nausea or vomit.
• No ≥ grade 2 sensory peripheral neuropathy.
• A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
• Infectious disease or inflammation with body temperature ≥ 38 ℃.