Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer
NCT ID: NCT02170090
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
789 participants
INTERVENTIONAL
2014-04-30
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
NCT03768414
Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy or in Front of Radical Resection of BTC
NCT03673072
A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma
NCT03081039
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
NCT04677504
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
NCT04066491
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Based on the data of the BILCAP trial showing an improvement in median overall survival for capecitabine compared to observation alone presented at the annual meeting of the American Society of Clinical Oncology on June 4th 2017 in Chicago by the British BILCAP trial group, capecitabine has evolved as the new standard of care after curative intent resection of biliary tract cancer.
Based on these data the comparative efficacy of gemcitabine/cisplatin and capecitabine had to be established.
Therefore, the ACTICCA trial was amended to compare gemcitabine and cisplatin to the newly established standard regimen in the adjuvant setting capecitabine, aiming for superiority of the combination regimen vs. the oral monotherapy This was based on the BILCAP protocol, applying the similar dosing, assessments and dose modifications as in BILCAP, including dose calculation and patient diary.
As data of recent trials like the French PRODIGE 12/ACCORD 18 trial have clearly shown that in terms of efficacy of an adjuvant chemotherapy there is no difference between cholangiocarcinoma and gall bladder carcinoma, these two subtypes are pooled and location was added as an stratification factor.
Randomization will be 1:1 with adjuvant CTx for 24 weeks and imaging every 12 weeks in the experimental arm and standard of care (capecitabine) and observation in the control arm.
The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS, safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gemcitabine plus Cisplatin
Chemotherapy will be administered on days 1 and 8 every 3 weeks, Cisplatin (25 mg per square meter of body-surface area) and Gemcitabine (1000 mg per square meter) for 24 weeks (8 cycles)
and Observation
Gemcitabine
Gemcitabine 1000mg/m2
Cisplatin
Cisplatin 25mg/m2
Capecitabine
Capecitabine will be administered from day 1 to 14 every 3 weeks (1250 mg per square meter of body-surface area, twice daily) for 24 weeks (8 cycles)
and Observation
Capecitabine
Capecitabine 1250mg/m2
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine
Gemcitabine 1000mg/m2
Cisplatin
Cisplatin 25mg/m2
Capecitabine
Capecitabine 1250mg/m2
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
Cancer Research UK
OTHER
Australasian Gastro-Intestinal Trials Group
NETWORK
Dutch Cancer Society
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henning Wege
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, City state of 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
Padua, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Stein A, Arnold D, Bridgewater J, Goldstein D, Jensen LH, Klumpen HJ, Lohse AW, Nashan B, Primrose J, Schrum S, Shannon J, Vettorazzi E, Wege H. 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 phase III trial. BMC Cancer. 2015 Jul 31;15:564. doi: 10.1186/s12885-015-1498-0.
Related Links
Access external resources that provide additional context or updates about the study.
Gemox versus surveillance following surgery of localized biliary tract cancer: Results of the PRODIGE 12-ACCORD 18 (UNICANCER GI) phase III trial. Edeline, Bonnetain et al.
Adjuvant capecitabine for biliary tract cancer: The BILCAP randomized study. Primrose, Fox et al.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-517340-61-00
Identifier Type: CTIS
Identifier Source: secondary_id
ACTRN12615001283561
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTICCA-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.