A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer - Norwegian Pancreatic Cancer Trial-3 (NORPACT 3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Resection rate (of the pancreatic tumour)
研究概览
简要总结
NORPACT-3 is a nationwide, Norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. Eligible patients are treated with primary 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. The primary aim is a national resection rate of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy, with adequate overall survival and morbidity/mortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival >20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (Clavien Dindo grade 3) ≤40%).
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, 2021) (Appendix 3)
- •Nx, M0 (UICC 8th version, 2016)
- •Cytological or histological confirmation of adenocarcinoma
- •Age >18 year
- •Considered able to receive primary chemotherapy and possible surgery
- •Written informed consent
排除标准
- •Co-morbidity or performance status precluding primary chemotherapy
- •Co-morbidity or performance status precluding pancreatectomy
- •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
Resection rate (of the pancreatic tumour)
时间窗: From November 2024-December 2027
Resection rate: National target of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy.
次要结局
- R0 resection rate(From November 2023-December 2027)
- Overall survival(From November 2024-December 2027)
- Mortality after surgical resection(From November 2024-December 2027)
- Morbidity after surgical resection(From November 2024-December 2027)
- Number of patients evaluated at national MDT undergoing resection(From November 2024-December 2027)
- Adverse events(From November 2023-December 2027)
- Quality of life EORTC QLQ-PAN26(Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.)
- Quality of life EQ-5D-5L(Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.)
- Quality of life EORTC QLQ-C30(Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.])
研究者
Knut Jørgen Labori
Professor of Surgery, Senior consultant surgeon
Oslo University Hospital