Trial Name: ACTICCA-1: Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gall bladder carcinoma (ACTRN12615001283561).
Patients Involved: Patients with histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection.
Treatment Given: Adjuvant chemotherapy with gemcitabine and cisplatin compared vs. observation.
Rationale for Treatment: It is hoped that the findings of this study will provide details on whether giving cisplatin and gemcitabine chemotherapy following surgery for cancer of the biliary tract is a safe and effective treatment to reduce the chance of disease progression and increase survival time and quality of life.
Recruitment and sites involved: The trial opened in July 2016. The aim is to recruit 50 patients from 15 Australian sites over a 24 month period. To date a total of 49 sites have opened this trial, 6 from Australia, 19 from Germany and 18 from the UK.
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Any trial correspondence should be directed to the ACTICCA Trial Coordinator via email email@example.com.