Unresectable locally advanced pancreatic cancer
Conditions
Interventions
1 course:14 days. FOLFIRINOX
L-OHP, l-LV, CPT-11 and 5-FU on day1 Conversion therapy will be done with resectable cancer.
Sponsors
Yokohama City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Invasive pancreatic ductal carcinoma histologically confirmed 2)None of metastatic lesions by laparoscopy. 3)Patients with no previous chemotherapy for pancreatic cancer. 4)ECOG Perfomance status must be 0 or 1. 5)Patients must be >=20 years old and <=75 years old at the time of consent. 6)Life Expectancy must be >=8 weeks. 7)Having of measurable lesions must be required(RECIST v1.1). 8)The following criteria must be satisfied for primary lesion(NCCN guideline v1.2014). a)Cancerous stricture of superior mesentric artery(SMA) or celiac artery b)Occlusion of superior mesentric vein(SMV) or portal vein(PV) cannot to be reconstructed c)Cancerous invasion or cancerous stricture of Paraaorta 9)The following criteria must be satisfied in laboratory tests conducted within 7 days before enrollment. And G-CSF, Erythropoetin, Blood products and transfusion must be untreated within 7days before enrollment. -White blood cell count >=3,500 /mm3 ,<=12,000/mm3 -Neutrophil count >=2,000 /mm3 -Hemoglobin >= 9.0 g/dL -Platelet count >=100,000 /mm3 -Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice) -AST <=150 IU/L -ALT <=150 IU/L -Serum Creatinine <=1.5 mg/dL 10)Patient must have signed the consent form.
Exclusion criteria
Exclusion criteria: 1)Severe drug hypersensitivity 2)Severe dysesthesia with functional disorder 3)homozygote(UGT1A1 *6/*6, UGT1A1 *28/*28) or heterozygote(UGT1A1 *6/*28) 4)Prior treatment(chemotherapy or radiation) 5)Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 5 year) except carcinoma in situ or intramucosal cancer 6)Infections that needs systemic treatment. 7)Pregnant females or being suspected, or nursing mothers. 8)Severe nervous disorder or mental disorder. 9)Transufusion, Blood products and G-CSF tried within 7days before enrollment. 10)Much pleural effusion, ascites fluid, pericardial fluid. 11)Jaundice 12)Congestive heart failure, symptomatic cerebrovascular accident, uncontrolable arrhythmia, and history of myocardial infarction in 12 months 13)Severe interstitial pneumonia or pulmonary fibrosis. 14)Diarrhea(to bring troubles in patients who have stoma) 15)Active peptic ulcer, paresis of intestine and ileus 16)Uncontrolled diabetes mellitus(DM) or DM with nervous disorder. 17)Need continuous medication of atazanavir sulfate. The subject who was determined by investigator that being not adequate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the ratio of R0 resection | — |
Secondary
| Measure | Time frame |
|---|---|
| the ratio of R0+R1 resection, Response rate, Progression Free Survival: PFS, Overall Survival: OS, Safety | — |
Countries
Japan
Contacts
Public Contactryutaro mori
Yokohama City University Department of Gastroenterological Surgery
Outcome results
None listed