Nationwide Implementation Program for Optimal Multidisciplinary Management and Resection of Locally Advanced Pancreatic Cancer (PREOPANC-4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- In-hospital mortality
研究概览
简要总结
A prospective, nationwide, implementation program of the international standard of excellence for locally advanced pancreatic cancer (LAPC) care in the Netherlands (2021[7]-2030[6]), including a multidisciplinary training program by the four leading international expert centers.
The PREOPANC-4 project aims a safe and patient-centered implementation of the international standards of excellence for LAPC (surgery) in the Netherlands.
详细描述
Rationale:
Non-metastasized locally advanced pancreatic cancer (LAPC) is diagnosed in 35% of all pancreatic cancer patients and is traditionally treated with palliative care. Recently, the multidisciplinary management of LAPC has evolved by the introduction of modern multi-agent induction chemotherapies, leading to an increased resection rate and improved outlook for five-year survival. In contrast, five-year survival after chemotherapy without surgery is virtually non-existent. In the Netherlands, the LAPC resection rate after induction chemotherapy remains low with 8% versus 25% in international centers of excellence, leading to missed opportunities for five-year survival in a selected subgroup of LAPC patients. Explanations for this large difference include the spectrum of chemotherapy use, interpretation of diagnostics, patient selection, and surgical techniques.
Objective:
A safe and patient-centered implementation of the international standards of excellence for LAPC (surgery) in the Netherlands.
Study design:
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
- •Age 18 years or older
- •Pathology-confirmed (LAPC)*
- •CT-based non-progressive disease (RECIST criteria) after at least 4 months of systemic chemotherapy ([m]FOLFIRINOX / gemcitabine-nab-paclitaxel).
排除标准
- •Metastatic pancreatic cancer prior to induction chemotherapy.
- •According to the Dutch Pancreatic Cancer Group (DPCG) definition: >90 degrees arterial tumor involvement (i.e. superior mesenteric artery, celiac axis, and/or hepatic artery) and/or portovenous involvement of either >270 degrees or occlusion.
结局指标
主要结局
In-hospital mortality
时间窗: Yearly assessment throughout the inclusion period
Mortality after resection (during primary hospitalization)
In-hospital major morbidity
时间窗: Yearly assessment throughout the inclusion period
Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization)
Resection rate
时间窗: Immediately after completing the inclusion period (December 31, 2024).
Resection rate of the pancreatic tumor
Overall survival (OS)
时间窗: After completing the follow-up period (December 31, 2029)
OS from time of resection (mOS, 1-year OS \& 5-year OS)
次要结局
- Shared decision-making: patients' healthcare satisfaction(Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.)
- R0 resection rate(Immediately after completing the inclusion period (December 31, 2024).)
- Quality of life(Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.)
研究者
M.G. Besselink
prof. dr. M.G. Besselink
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)