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

JRCT ID: jRCTs051200130

Registered date:02/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Borderline resectable pancreatic ductal adenocarcinoma
• Date of first enrollment: 02/02/2021
• Target sample size: 110
• Study type: Interventional

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 Outcome: 3-year survival rate
• Secondary Outcome: Clinical 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
• Gender: Both

Include criteria

Inclusion 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 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

Related Information

• Primary Sponsor: Kobayashi Syogo