Adjuvant chemotherapy versus NEOadjuvant gemcitabine/ oxaliplatin plus adjuvant gemcitabine in resectable PAncreatic Cancer: a randomized multicenter phase III study - NEOPAC

Gesellschaft für Studienmanagement und Onkologie mbH0 个研究点目标入组 310 人开始时间: 2013年11月19日最近更新: 2018年1月8日

试验速览

暂无简介。

•1.Resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
•2.T1-3, Nx, M0 (UICC 6th version, 2002)
•3.Infiltration of the portal vein (< 180°) is not an exclusion criterion
•4.Cytologic or histologic confirmation of adenocarcinoma
•5.Age > 18 years
•6.Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 310
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 310

•1.Contraindication for Whipple procedure
•2.Infiltration > 180° of the portal vein
•3.Abutment of the tumor to the superior mesenteric artery
•4.Infiltration of the superior mesenteric artery or the celiac trunk
•5.Chronic neuropathy > grade 2
•6.WHO performance score > 2
•7.Female patients in child-bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)
•8.Pregnant or lactating women
•9.Mental or organic disorders which could interfere with giving informed consent or receiving treatments
•10.Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer
•11.Percutaneous biopsy of the primary tumor

发起方

Gesellschaft für Studienmanagement und Onkologie mbH