Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer - a Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Median Overall Survival
研究概览
简要总结
This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer
详细描述
This is a multicenter pragmatic prospective observational study including Nordic hospitals treating patients with borderline resectable and locally advanced pancreatic cancer. Eligibility will be assessed at regional multidisciplinary tumor boards. Patients with borderline resectable and locally advanced (non-endocrine) pancreatic cancer according to the National Comprehensive Cancer Network (NCCN) and the International Study Group of Pancreatic Surgery (ISGPS) are eligible for inclusion. The study is observational. Quality of life will be assessed in all study participants. The primary outcomes are exploration rates, resection rates and overall survival.
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
- •Confirmed or suspected invasive pancreatic primary tumor
- •Tumor classified as borderline resectable or locally advanced disease according to NCCN guidelines
排除标准
- •Suspected endocrine tumor
- •Suspected non-pancreatic periampullary tumor
- •Distant metastasis
- •Age < 18 years
- •Patient unable to understand verbal or written information interfering with informed consent or treatment
- •Mental or organic disorder interfering with informed consent or treatments
结局指标
主要结局
Median Overall Survival
时间窗: From date of inclusion until the date of death from any cause, assessed up to 72 months
Median overall survival for patients with locally advanced pancreatic cancer stratified for treatment allocation
Resection
时间窗: From the time of inclusion to end of study follow up or date of death from any cause, whichever came first, up to 72 months
Rates of resection among patients with locally advanced pancreatic cancer stratified for treatment allocation
次要结局
- Predictors of resectability(From the time of inclusion to end of study follow up or date of death from any cause, whichever came first, up to 72 months)
- Quality of Life at baseline(At first visit/inclusion)
- Quality of Life at 3 months after inclusion(Quality of Life at 3 months after inclusion)
- Oncological treatment compliance(From the time of inclusion to end of study follow up or date of death from any cause, whichever came first, up to 72 months)
- Chemotherapy response(From the time of inclusion to end of study follow up or date of death from any cause, whichever came first, up to 72 months)
- Quality of Life at 12 months after inclusion(Quality of Life at 12 months after inclusion)
- Quality of Life at 24 months after inclusion(Quality of Life at 24 months after inclusion)
- Quality of Life at 6 months after inclusion(Quality of Life at 6 months after inclusion)
- Quality of Life at 9 months after inclusion(Quality of Life at 9 months after inclusion)