Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Overall survival
研究概览
简要总结
Radical surgical resection is the only curative treatment option for pancreatic cancer, but borderline resectable tumors have a high probability of incomplete exeresis. Although neoadjuvant therapy can improve the chances of complete exeresis, not all patients respond as expected.
详细描述
Pancreatic cancer is an important cause of cancer-related death worldwide. Radical surgical resection still is the only curative treatment option today, but not all tumors are considered resectable. Among resectable tumors, some are deemed borderline and have a high probability of incomplete exeresis. Neoadjuvant therapy (NAT) can be a game-changer for borderline cases, and there is a lack of evidence on the predictive factors associated with resectability after neoadjuvant treatment.
This study aims to assess the prognostic factors for resectability and survival after NAT in type A borderline resectable pancreatic ductal adenocarcinoma patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients ≥18 years old.
- •Both sexes.
- •Diagnosed with a type A BR-PDAC between January 2010 and December
- •Minimum follow-up period of 12 months.
排除标准
- •Patients diagnosed with a type B or type C BR-PDAC.
- •Patients diagnosed with a type A BR-PDAC who had disease progression prior to receiving NAT.
结局指标
主要结局
Overall survival
时间窗: From starting NAT until the end of the observation period (December 2019) or death (whichever occurs first).
Time until death (from any cause)
The number of type A BR-PDAC patients who, after receiving NAT (≥3 cycles), undergo resection.
时间窗: From 6 weeks until the end of the observation period (December 2019) or death (whichever occurs first)
NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks.
The evolution of the degree of vascular involvement in 64-MDCT scans from starting NAT until the surgical exploration.
时间窗: Up to 16 weeks
We will evaluate the tumor's anatomical relationship with neighboring vascular structures before and after NAT, measured with 64-MDCT (multidetector computerized tomography) scans. NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks.
The evolution of the plasmatic levels of CA 19-9
时间窗: From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
Progression-Free Survival
时间窗: From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
Time until disease progression
The evolution of the plasmatic levels of CA 19-9 from starting NAT until the surgical exploration.
时间窗: Up to 16 weeks
NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks.
The evolution of the degree of vascular involvement in 64-MDCT scans
时间窗: From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans.
次要结局
- The number (percentage) of patients surgically explored at the end of the observation period.(From starting NAT until end of the observation period (December 2019))
- The Resection Rate at the end of the observation period.(From starting NAT until end of the observation period (December 2019))
- The number (percentage) of deaths at the end of the observation period.(From starting NAT until end of the observation period (December 2019))
- The number (percentage) of patients considered responders at the end of the observation period.(From starting NAT until end of the observation period (December 2019))
- The number (percentage) of patients presenting disease progression at the end of the observation period.(From starting NAT until end of the observation period (December 2019))
- The number (percentage) of patients presenting stable disease at the end of the observation period.(From starting NAT until end of the observation period (December 2019))
研究者
BUSQUETS, JULI
Principal Investigator
Hospital Universitari de Bellvitge