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.
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 ℃.
