NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051200130

Registered date:02/02/2021

NACRT(GA-RT) vs NAC(GA) for BRPC

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBorderline resectable pancreatic ductal adenocarcinoma
Date of first enrollment02/02/2021
Target sample size110
Countries of recruitment
Study typeInterventional
Intervention(s)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

Outcome(s)

Primary Outcome3-year survival rate
Secondary OutcomeClinical effect, safety, Resection rate, R0 resection rate, Pathological effect, Local recurrence rate,Overall survival (OS), Recurrence free suvival (RFS)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 80age old
GenderBoth
Include criteriaInclusion criteria (1)Histological or cytological evidence of pancreatic ductal adenocarinoma (2)Age>=20,Age<80 (3)PS:0-1(ECOG grade) (4)Radiological diagnosis as BR-PC according to NCCN guideline version 1.2020 as follows 4-1.Solid tumor contact with the SMV or PV of >180deg 4-2.Solid tumor contct with CA,CHA,SMA of <=180deg 4-3.Solid tumor contact with the inferior vena cava(IVC) 4-4.Solid tumor contact with CA,CHA>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 <=2.0mg/dL (or <=3.0mg/dL in patients with intervention for obstructive jundice) 6-5.AST(GOT),ALT(GPT) <=150U/L 6-6.serum creatinine <=1.2mg/dL 6-7.creatinine clerance >=60mL/min(according to Cockroft-Gult calculating formula) 6-8.SpO2>=90% (7)enough tolerance for pancreatectomy (8)acquisition of written informed concent
Exclude criteriaExclusion 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

Related Information

Contact

Public contact
Name Syogo Kobayashi
Address 2-15, Yamadaoka, Suita City, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3251
E-mail skobayashi@gesurg.med.osaka-u.ac.jp
Affiliation Osaka University Hospital
Scientific contact
Name Syogo Kobayashi
Address 2-15, Yamadaoka, Suita City, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3251
E-mail skobayashi@gesurg.med.osaka-u.ac.jp
Affiliation Osaka University Hospital