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).A randomized, multidisciplinary, multinational AIO/DGAV/DGVS phase III trial. - ACTICCA-1

IVERSITäTKLINIKUM HAMBURG-EPPENDORF0 sites781 target enrollmentNovember 6, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 6, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IVERSITäTKLINIKUM HAMBURG-EPPENDORF

•Eligibility criteria for enrolment phase
•1\. 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
•2\. Written informed consent
•3\. No prior chemotherapy for biliary tract cancer
•4\. 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
•5\. 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)
•6\. Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
•7\. No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
•8\. 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)

•Eligibility criteria for enrolment phase
•1\. 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
•2\. Written informed consent
•3\. No prior chemotherapy for biliary tract cancer
•4\. 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
•5\. 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)
•6\. Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
•7\. No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
•8\. 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)