2024-517340-61-00
尚未招募
3 期
Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial)
University Medical Center Hamburg-Eppendorf29 个研究点 分布在 4 个国家目标入组 573 人开始时间: 2024年11月12日最近更新:
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- University Medical Center Hamburg-Eppendorf
- 入组人数
- 573
- 试验地点
- 29
- 主要终点
- Disease free survival (DFS)
概览
简要总结
The primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin compared with standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients with BTC after complete resection in terms of DFS
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Eligibility criteria for enrolment phase
- •Suspicion of or histologically/cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) scheduled for radical surgical therapy
- •Written informed consent
- •No prior chemotherapy for biliary tract cancer
- •No previous malignancy within 3 years or concomitant malignancy, except: those with a 5 year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately treated in situ cervical cancer
- •No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia)
- •Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
- •No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
- •Fertile women (< 1 year after last menstruation) and procreative men willing and able to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- •No pregnancy or lactation
排除标准
- •Eligibility criteria for enrolment phase
- •Suspicion of or histologically/cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) scheduled for radical surgical therapy
- •Written informed consent
- •No prior chemotherapy for biliary tract cancer
- •No previous malignancy within 3 years or concomitant malignancy, except: those with a 5 year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately treated in situ cervical cancer
- •No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia)
- •Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
- •No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
- •Fertile women (< 1 year after last menstruation) and procreative men willing and able to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- •No pregnancy or lactation
结局指标
主要结局
Disease free survival (DFS)
Disease free survival (DFS)
次要结局
- Disease free survival rate at 24 months (DFSR@24)
- Recurrence free survival (RFS)
- Overall survival (OS)
- Safety and tolerability of adjuvant chemotherapy
- Quality of life (QoL)
- Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD)
- Rate and severity of biliary tract infections
- Patterns of disease recurrence
- Locoregional control
研究者
Prof. Dr. med. Henning Wege
Scientific
University Medical Center Hamburg-Eppendorf
研究点 (29)
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