Invasive ductal adenocarcinoma
Conditions
Interventions
neoadjuvant chemotherapy 2 courses of NAC-GA 1.nab-paclitaxel (Day1,8,15) 125mg/m2 30 min div administration 2.Gemcitabine (Day1,8,15) 1,000mg/m2 30 min div administration
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous 2.case with measurable lesion 3.First line treatment 4.PS(ECOG)0-1 5.>=20 years old and <80 years old 6.The following criteria must be satisfied in laboratory tests within 14 days of registration WBC count<=12,000/mm3 Neutrophil count>=1,500/mm3 Hb>=9.0g/dl Plt >=100,000/mm3 T.Bil <2.0mg/dl (<3=.0mg/dl in biliary drainage case) Serum Cr<=upper limits of normal (ULN) AST, ALT<=2.5xULN 7. Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1.Severe drug hypersensitivity 2.Multiple primary cancers within 5 years 3.Severe infection 4.With grade2 or more severe peripheral neuropathy 5.Interstitial pneumonia or pulmonary fibrosis 6.With uncontrollable pleural effusion or ascites 7.With uncontrollable diabetes mellitus 8.With uncontrollable heart failure, angina, hypertension, arrhythmia 9.With severe neurological/psychological symptoms 10.With watery diarrhea 11.Pregnant or lactating women or women with unknown or suspected pregnancy 12.Inappropriate patients for entry on this study in the judgement of the investigator 13.Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival time from the first day of protocol therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Recurrence free survival from the first day of protocol therapy 2.Safety of the protocol therapy(Adverse effect) 3.Morbidity based on Clavien Dindo classification of more than Grade3 4.Response rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of mornalization, reduction rate of SUVmax value on PET-CT(limited only for PET-CT available institutions) 5.Chemotherapeutic effect grade based on Evans classification. 6.Resection rate 7.R0 resection rate 8.Surgical data(operative time, blood loss,transfusion, postoperative hospital day) 9.The overall morbidity rates(Reoperation, rate of re-admission, mortality) 10.Number of patient rate in postoperative adjuvant therapy(entry rate, completion rate) 11.Dose intensity | — |
Countries
Japan
Contacts
Public ContactKen-ichi Okada
Wakayama Medical University Second Department of Surgery
Outcome results
None listed