Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Recurrence-free survival
研究概览
简要总结
The goal of this observational study is to compare chemotherapy types that are given after surgery for biliary tract cancers. The main question it aims to answer is:
Are any of the chemotherapy regimens more effective in preventing recurrence, providing longer survival, or having less toxicity?
Nationwide multicenter retrospective data will be collected.
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
- •Histologically confirmed biliary tract cancer (intrahepatic, perihilar, distal, gallbladder)
- •Underwent curative-intent resection
排除标准
- •Patients with a disease without histological confirmation
- •Ampullary cancers
研究组 & 干预措施
Patient with biliary tract cancer
Patients with biliary tract cancer, who underwent resection and received adjuvant chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Recurrence-free survival
时间窗: From the date of adjuvant chemotherapy initiation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 180 months
The length of time from the start of adjuvant chemotherapy to the date of the first loco-regional or systemic recurrence or death
Overall survival
时间窗: From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months
The length of time from the start of adjuvant chemotherapy to the date of death
次要结局
- 2-year recurrence-free survival(From start of adjuvant chemotherapy to the date of recurrence or death in the first 2 years)
- 2-year overall survival(From start of adjuvant chemotherapy to the date of death in the first 2 years)
- The number of patients experienced toxicities(From the date of initiation of the first cycle of adjuvant chemotherapy until 1 month after the last cycle of adjuvant chemotherapy)
研究者
Erman Akkus
Principle Investigator
Ankara University