Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) A randomized, multidisciplinary, multinational AIO/DGAV/DGVS phase III trial.

niversity Medical Center Hamburg-Eppendorf0 sites60 target enrollmentSeptember 2, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 2, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity Medical Center Hamburg-Eppendorf

•Eligibility criteria for treatment phase (before randomization)
•1\. Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumor entities (HCC/CCA) are excluded)
•2\. Macroscopically complete resection (R0/1\) within 6 (\-16\) weeks before scheduled start of chemotherapy
•3\. ECOG 0\-1
•4\. Age \>18 years
•5\. Adequate hematologic function: ANC \= 1\.5 x 10^9/L, platelets \= 100 x10^9/L, hemoglobin \= 9 g/dl or \= 5\.59 mmol/L
•6\. Adequate liver function as measured by serum transaminases (AST and ALT) \<\= 5 x ULN and bilirubin \<\= 3 x ULN
•7\. Adequate renal function, i.e. serum creatinine \<\= 1\.5 x ULN, glomerular filtration rate \= 60 mL/min (MDRD)
•8\. No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
•9\. No concurrent treatment with other experimental drugs or other anti\-cancer therapy, treatment in a clinical trial within 30 days prior to randomization

•1\. Prior chemotherapy for biliary tract cancer
•2\.Previous malignancy within 3 years or concomitant malignancy, except: non\-melanomatous skin cancer or adequately treated in situ cervical cancer
•3\. 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)
•4\. Psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
•5\. Serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
•6\. Fertile women (\< 1 year after last menstruation) and procreative men not willing or unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
•7\. Pregnant or lactating women