Comparative Study Between Immediate Surgery Versus Neoadjuvant Chemotherapy for Management of Resectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
This trial aimed to determine whether neoadjuvant chemoradiotherapy improves overall survival compared with upfront surgery, both followed by adjuvant chemotherapy in patients with resectable and borderline resectable pancreatic cancer.
详细描述
Pancreatic cancer is one of the solid cancers with the poorest treatment outcomes, and there is an urgent need to improve its treatment outcomes. Among these, resectable pancreatic cancer is known to show relatively good treatment outcomes with surgical resection, but the 5-year survival rate is still about 20%, which is still unsatisfactory.
Neoadjuvant therapy may increase the proportion of patients that actually receive chemotherapy and thereby improve survival. Furthermore, neoadjuvant therapy may increase the microscopically margin-negative (R0) resection rate and may identify patients with rapidly progressive disease who can be spared futile surgery.
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
- •Computed tomography (CT) with pancreatic protocol + vascular mapping
- •Histopathologically proven malignant by CT-guided or endoscopic ultrasound (EUS)-guided biopsy Resectable pancreatic cancer means no contact of the tumor with the Superior mesenteric artery, Celiac axis & Common hepatic artery, and contact of the tumor but ≤90° contact with the superior mesenteric vein & portal vein.
排除标准
- •Borderline resectable & locally advanced pancreatic cancer
- •Tumor at the tail of the pancreas.
- •Metastatic pancreatic cancer
- •Unfit patients for surgery.
研究组 & 干预措施
Immediate surgery group
Patients will undergo upfront surgery, then adjuvant chemotherapy.
干预措施: Immediate surgery (Procedure)
Neoadjuvant chemotherapy group
Patients will undergo neoadjuvant chemotherapy, then surgery.
干预措施: Neoadjuvant chemotherapy (Procedure)
结局指标
主要结局
Overall survival rate
时间窗: 1 year post-procedure
Overall survival will be measured as the time between date of randomization and date of death from any cause or date of last follow-up if alive.
次要结局
- Time to locoregional recurrence(1 year post-procedure)
- Achieve of R0 Resection(1 year post-procedure)
- Disease free survival(1 year post-procedure)
- Time to distant metastasis(1 year post-procedure)
- Incidence of postoperative complications(1 year post-procedure)
研究者
Abdelrahman Mohamed Salah
Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.
Minia University