ACTICCA-1
Research type
Research Study
Full title
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.
IRAS ID
173496
Contact name
John Bridgewater
Contact email
Sponsor organisation
University Medical Center Hamburg-Eppendorf
Eudract number
2012-005078-70
Clinicaltrials.gov Identifier
CRCTU Reference Number, HE3015
Duration of Study in the UK
5 years, 6 months, 1 days
Research summary
Biliary tract tumours are relatively rare, accounting for 0.7% of malignant tumours in adults, with approximately 1200 new cases registered each year in England and Wales. The 1-year and 5-year survival is poor at 22% and 9% respectively (Cancer Survival Trends in England and Wales 1971 – 1995). Approximately 15-20% of cases are suitable for surgical resection but the outlook remains poor with survival at 5 years approximately 15% (Cancer Survival Trends in England and Wales 1971 – 1995. Most tumours are advanced at presentation and are unsuitable for surgical resection.
The ACTICCA-1 trial will investigate the role of adjuvant chemotherapy with Cisplatin and Gemcitabine compared to surveillance. This study will determine whether the Cisplatin and Gemcitabine regimen which is effective in advanced disease will show a benefit in the adjuvant setting.
This is an international, multicentre, prospective, randomised controlled trial comparing adjuvant treatment with Cisplatin and Gemcitabine with no adjuvant treatment in patients who have undergone a complete macroscopic resection of biliary tract cancer. Patients will be followed up for a period of 5 years, primarily assessing disease free survival and overall survival at 2 and 5 years respectively. Quality of Life sub studies are planned to be investigated within the trial also.
The results of this study will be used to further define the optimum management for patients who undergo a complete resection of their biliary tract cancer. This result could have the potential to change the current practice for treating these patients.REC name
London - Central Research Ethics Committee
REC reference
15/LO/1044
Date of REC Opinion
10 Jul 2015
REC opinion
Further Information Favourable Opinion