Borderline resectable pancreatic ductal adenocarcinoma Borderline resectable pancreatic cancer, Prospective randomized control study, Neoadjuvant chemotherapy, Neoadjuvant chemoradiotherapy
Conditions
Interventions
Group GA
GEM
1000mg/m2,intraverous infusion on Day1,Day8,Day15
neb-PTX
125mg,intravenous infusion on Day1,Day8,Day15
Group GA-RT
GEM
800mg/m2,intravenous infusion on Day1,Day8,Day15,Day29
nab-PTX
100mg,intravenous infusion on Day1,Day8,Day15,Day29
RT
2.0 Gy/day,from Monday to Friday every week,total 50.0 Gy
Sponsors
Akita Hirofumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria (1)Histological or cytological evidence of pancreatic ductal adenocarinoma (2)Age>=20,Age180deg 4-2.Solid tumor contct with CA,CHA,SMA of 180deg without the involvement (5)The expected prognosis>=6months (6)Patients with normal function of principle organs(bone marrow,liver,kidney,lung,etc) 6-1.Neutrocyte >=2,000/mm3 6-2.Pltelet >=100,000/mm3 6-3.Hemoglobin >=9.5g/dL 6-4.Total bilirubin =60mL/min(according to Cockroft-Gult calculating formula) 6-8.SpO2>=90% (7)enough tolerance for pancreatectomy (8)acquisition of written informed concent
Exclusion criteria
Exclusion criteria: Exclusion creiteria (1)Unresectable pancreatic cancer as follows 1-1.distant metastsis 1-2.peritoneal dissemination,positive cytology of ascites 1-3.paraortic lymph node metastasis 1-4.the severe stenosis or obstruction of PV or SMV which it is impossible to construct 1-5.SMV invasion is extent to the inferior border of duodenal horizontal limb which is hard to construct 1-6.multiple pancreatic cancers 1-7.In cases attending doctor deemed impossible to undergo radical surgery (2)Patients with anamnesis of pulmonary fibrosis or emphysema,or patients with severe respirtory disability (for example,%VC<=50% or FW|EV1.0<1L) (3)Patients with active infection except viral hepatitis (4)Patients with sever generl complications,for example cardicac failure,renal failure,helatic failure, uncontrollable diabetes,etc. (5)Patients with a certin amount of ascites or pleural effusion (6)Patients with the metastasis of central nervous system (7)Patients with other invasive cancer concurrently (8)Patients in pregnancy (9)Patients with severe mental disability (10)Patients with severe drug induced hypersensitivity syndrome (11)Patients who are judged inappropriate for the entry into this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effect, safety, Resection rate, R0 resection rate, Pathological effect, Local recurrence rate,Overall survival (OS), Recurrence free suvival (RFS) | — |
Contacts
Public ContactHirofumi Akita
The University of Osaka Hospital
Outcome results
None listed