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Summary

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)

Acronym:

ACTICCA-1

ACTRN/NCT /ethics:

ACTRN12615001283561 NCT02170090 Ethics: 264.16

Scientific title:

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)

Trial & patient characteristics

Cancer TypeGall Bladder
Trial TypeTreatment
PhasePhase III
Age Range18+ years
SexBoth
Molecular Target-
Tumour StreamGall Bladder
Cancer StageAll stages
Anticipated Start Date2014-04-01
Anticipated End Date2022-04-01

Trial Summary

ACTICCA-1 is a clinical research study for people who have a cancer of the biliary tract (cancer of the gall bladder or bile duct, also known as cholangiocarcinoma in medical terms) which has been removed in an operation. This is a multicentre, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. observation alone in patients after curative intent resection of cholangiocarcinoma and muscle invasive gall bladder carcinoma.

Lay Summary

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)

Sponsor / Cooperative group

Universitsklinikum Hamburg-Eppendorf

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlex Scott-Hoy
Emailalex.scott-hoy@sa.gov.au
Phone08 8204 4830
Principal InvestigatorProfessor Chris Karapetis
Recruitment StatusRecruiting