Nordic Multicentre Un-blinded Phase II Randomized Controlled Trial (RCT) Evaluating the Additional Efficacy of Adding Chemotherapy Prior to Resection of a Pancreatic Head Malignancy to Avoid Early Mortality in Those Ultimately Resected
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 13
- 主要终点
- Overall survival 18 month after randomization
研究概览
简要总结
This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection
详细描述
Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States. Surgical resection remains the only potentially curative treatment. However, the median survival of patients undergoing pancreatic resection alone is 16-23 months. The administration of adjuvant chemotherapy leads to an improvement in overall survival. Thus, completion of multimodality treatment (MMT) is the ideal goal and standard of care for treatment of pancreatic ductal adenocarcinoma (PDAC).
Currently, the surgery-first (SF) strategy is the most universally accepted approach to resectable PDAC (and is the standard of care in Norway), but the optimal sequence of surgery and chemotherapy remains unclear.
The purpose of this study is to further investigate the additional efficacy of neoadjuvant chemotherapy to the standard treatment for resectable cancer of the pancreatic head (surgery followed by adjuvant chemotherapy).
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
- •T1-3, Nx, M0 (UICC 7th version, 2010)
- •Cytologic or histologic confirmation of adenocarcinoma
- •Age > 18 year and considered fit for major surgery
- •Written informed consent
- •Considered able to receive the study specific chemotherapy
排除标准
- •Co-morbidity precluding pancreaticoduodenectomy
- •Chronic neuropathy ≥ grade 2
- •WHO performance score > 2 • Granulocyte count < 1500 per cubic millimetre
- •Platelet count < 100 000 per cubic millimeter
- •Serum creatinine > 1.5 UNL (upper limit normal range)
- •Albumin < 2,5 g/dl
- •Female patients in child bearing age not using adequate contraception, pregnant or lactating women • Mental or organic disorders which could interfere with informed consent or treatments
- •Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer
- •Percutaneous tumor biopsy
- •Any reason why, in the opinion of the investigator, the patient should not participate
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
Surgery and then postoperative adjuvant chemotherapy
Surgery and then postoperative adjuvant chemotherapy
干预措施: Pancreatic surgery (Procedure)
Surgery and then postoperative adjuvant chemotherapy
Surgery and then postoperative adjuvant chemotherapy
干预措施: 5-FU (Drug)
Surgery and then postoperative adjuvant chemotherapy
Surgery and then postoperative adjuvant chemotherapy
干预措施: Oxaliplatine (Drug)
Surgery and then postoperative adjuvant chemotherapy
Surgery and then postoperative adjuvant chemotherapy
干预措施: Irinotecan (Drug)
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
干预措施: 5-FU (Drug)
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
干预措施: Oxaliplatine (Drug)
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
干预措施: Irinotecan (Drug)
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
干预措施: Pancreatic surgery (Procedure)
结局指标
主要结局
Overall survival 18 month after randomization
时间窗: 18 month
Overall survival at 18 months after date of randomization (intention to treat)
次要结局
- Overall mortality at one year following commencement of allocated treatment.(1 year)
- Histopathological response(Arm 1: Baseline and Arm 2; 4 weeks after baseline)
- Disease-free survival(until 5 years after surgery)
- Complication rate after surgery(30 and 90 days)
- Health related Quality of Life(until 5 years after surgery)
- Health economics(until 5 years after surgery)
- Feasibility of neoadjuvant and adjuvant chemotherapy(Baseline)
研究者
Knut Jørgen Labori
Senior consultant surgeon, Professor of Surgery
Oslo University Hospital