Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 5
- 主要终点
- 2-year survival rate
研究概览
简要总结
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.
详细描述
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer.
This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.
This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old or <75 years old
- •biopsy proven adenocarcinoma of the pancreas
- •no history of previous chemotherapy
- •borderline resectable pancreas cancer
- •no distant metastasis
- •WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
- •Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
- •Creatinine no greater than 1.5 times upper limit of normal
- •informed consent
排除标准
- •history of previous chemotherapy
- •history of radiation at >25% area of bone marrow
- •stage unspecified, with distant metastasis, recurrent pancreas cancer
- •history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study
- •pregnant, breast-feeding patient
- •uncontrolled or active infection
- •uncontrolled cardiopulmonary disease
研究组 & 干预措施
Neoadjuvant
Neoadjuvant - operation - maintenance chemotherapy
干预措施: Neoadjuvant chemoradiation (Drug)
Upfront surgery
Operation - adjuvant chemoradiation - maintenance chemotherapy
干预措施: Upfront surgery (Procedure)
结局指标
主要结局
2-year survival rate
时间窗: 2-year actual survival outcome
2-year actual survival outcome
次要结局
- Median survival(after at least of 2-years follow up of all participants)
- 1-year survival rate(after at least of 1-year follow up of all participants)
- local recurrence(within at least 2-years follow up)
- response rate after neoadjuvant chemoradiation(within 6 weeks after completion of neoadjuvant chemoradiation)
- efficacy of imaging study after neoadjuvant chemoradiation(within 3 weeks after operation)
- R0 resection rate(within 3 weeks after operation)
- curative resection rate(within 3 weeks after operation)
研究者
Jin-Young Jang
Associate professor
Seoul National University Hospital