Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - a Norwegian Population Based Observational Study (NORPACT-2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)
研究概览
简要总结
This is a Norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with neoadjuvant chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2015)
- •Nx, M0 (UICC 8 th version, 2016)
- •cytological or histological 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 pancreatectomy
- •chronic neuropathy ≥ grade 2
- •WHO performance score > 2
- •granulocyte count < 1500 per cubic millimetre
- •platelet count < 100 000 per cubic millimetre
- •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 physical disorders that could interfere with treatment of with the provision of informed consent
- •any reason why, in the opinion of the investigator, the patient should not participate
结局指标
主要结局
Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)
时间窗: 5 years
Patients who undergo surgical resection will be documented
次要结局
- 1-year progression-free survival rate(1-year after surgical resection)
- Disease-free survival(Disease-free survival at 5 years using Kaplan-Meier survival analysis)
- Radiological response(2-6 months after initiation of chemotherapy)
- Histopathological response(14-30 days post surgery)
- R0 resection rate(14-30 days post surgery)
- Overall survival from time of inclusion (intention to treat)(Overall survival rate at 5 years using Kaplan-Meier survival analysis)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 year after inclusion)
- Overall survival following resection(Overall survival rate at 5 years using Kaplan-Meier survival analysis)
- Overall survival after 1, 2, 3 and 5 years(1, 2, 3 and 5 years after inclusion)
- Complication rates after surgery classification systems)(30 and 90 days post surgery)
- Completion rates of all parts of multimodal treatment(Up to 1 year after inclusion)
- QoL (EORTC QLQ-30)(5 years)
- Performance status - Eastern Cooperative Oncology Group (ECOG)(5 years)
研究者
Knut Jørgen Labori
Consultant surgeon MD, PhD
Oslo University Hospital