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ACTIVE NOT RECRUITING

NCT02170090

PHASE3

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

Sponsor: Universitätsklinikum Hamburg-Eppendorf

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

789

Start Date

2014-04

Completion Date

2025-12

Last Updated

2025-03-30

Healthy Volunteers

Conditions

Cholangiocarcinoma Gall Bladder Carcinoma

Interventions

DRUG

Gemcitabine

Gemcitabine 1000mg/m2

DRUG

Cisplatin

Cisplatin 25mg/m2

DRUG

Capecitabine

Capecitabine 1250mg/m2

All enrolled patients will postoperatively be assessed for eligibility for the treatment phase. Additionally patients not previously enrolled into the trial for whatever reason (e.g. incidental finding during surgery) will be evaluated for eligibility. * 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) * Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start of chemotherapy * ECOG 0-1 * Age ≥18 years * Adequate hematologic function * Adequate liver function * Adequate renal function * No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy * No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization * Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women \<1 year after the onset of menopause (Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded) Criteria for initial study enrolment * Written informed consent * No prior chemotherapy for cholangiocarcinoma * No previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer * 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) * Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent * No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial * 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) * No pregnancy or lactation

Locations (67)

Bankstown Hospital

Bankstown, New South Wales, Australia

Nepean Hospital Cancer Care

Kingswood, New South Wales, Australia

St. George Hospital

Kogarah, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Townsville Hospital

Douglas, Queensland, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Fiona Stanley Hospital Perth

Murdoch, Western Australia, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

St. John of God

Subiaco, Western Australia, Australia

Kaiser-Franz-Josef Hospital

Vienna, Austria

Vejle Hospital

Vejle, Denmark

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, Germany

University Medical Center Aachen

Aachen, Germany

Charite Berlin

Berlin, Germany

University Medical Center Carl Gustav Carus

Dresden, Germany

University Medical Center Essen

Essen, Germany

Klinikum Esslingen

Esslingen am Neckar, Germany

University of Frankfurt

Frankfurt, Germany

University Medical Center Freiburg

Freiburg im Breisgau, Germany

University of Hannover

Hanover, Germany

University of Heidelberg

Heidelberg, Germany

University of Saarland

Homburg, Germany

University Medical Center Jena

Jena, Germany

Johannes Gutenberg University of Mainz

Mainz, Germany

University of Mannheim

Mannheim, Germany

University of Munich Grosshadern

Munich, Germany

University of Regensburg

Regensburg, Germany

University Medical Center Tuebingen

Tübingen, Germany

University of Ulm

Ulm, Germany

University Medical Center

Würzburg, Germany

Istituto Oncologico Veneto IRCCS

Padova, Padova, Italy

Azienda Ospedaliero Medica 2 Universitaria

Pisa, Pisa, Italy

Fondazione Policlinico Gemelli, Roma

Rome, Rome, Italy

Istituto Nazionale dei Tumori

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Academic Medical Center

Amsterdam, Netherlands

University Medical Center

Maastricht, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Auckland Hospital

Auckland, New Zealand

Hampshire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Addenbrooke's Hospital Cambridge

Cambridge, United Kingdom

Velindre Hospital Cardiff

Cardiff, United Kingdom

Western General Hospital Edinburgh

Edinburgh, United Kingdom

Beatson West of Scotland Cancer Centre Glasgow

Glasgow, United Kingdom

James Paget University Hospitals

Great Yarmouth, United Kingdom

Royal Surrey County Hospital Guildford

Guildford, United Kingdom

Princess Alexandra Hospital

Harlow, United Kingdom

Huddersfield Royal Infirmary

Huddersfield, United Kingdom

Guy's and St Thomas's Hospital London

London, United Kingdom

Hammersmith Hospital London

London, United Kingdom

Royal Free Hospital London

London, United Kingdom

University College London Hospital

London, United Kingdom

Maidstone Hospital

Maidstone, United Kingdom

Christie Hospital Manchester

Manchester, United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Churchill Hospital Oxford

Oxford, United Kingdom

Derriford Hospital Plymouth

Plymouth, United Kingdom

Weston Park Hospital Sheffield

Sheffield, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Clinical Research Directory

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (67)