Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).
This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
- •T1-3, Nx, M0 (UICC 6th version, 2002)
- •infiltration of the portal vein (<180°) is not an exclusion criterion
- •cytologic or histologic confirmation of adenocarcinoma
- •age >18 years
- •written informed consent
排除标准
- •contraindication for Whipple procedure
- •an infiltration >180° of the portal vein
- •abutment of the tumor to the superior mesenteric artery
- •infiltration of the superior mesenteric artery or the celiac trunk
- •chronic neuropathy > grade 2
- •WHO performance score >2
- •uncorrectable cholestasis (bilirubin > 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)
- •female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)
- •pregnant or lactating women
- •mental or organic disorders which could interfere with giving informed consent or receiving treatments
- •Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer
- •percutaneous biopsy of the primary tumor
研究组 & 干预措施
Neoadjuvant chemotherapy
After initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11).
干预措施: Neoadjuvant chemotherapy (Drug)
surgery
surgery
干预措施: surgery and Adjuvant chemotherapy (Procedure)
结局指标
主要结局
progression-free survival
时间窗: from date of randomization until date of progression, assessed up to 5 years
period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).
次要结局
- histology(at 6 months)
- overall survival(From date of randomization until date of death, assessed up to 5 years)
- complication(until 6 months)