Last updated on October 2017

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


Brief description of study

This is a multicentre, two stage, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (capecitabine) and observation in patients after curative intent resection of cholangiocarcinoma and muscle invasive gall bladder carcinoma.

Detailed Study Description

The ACTICCA-1 investigator initiated trial is funded by the Deutsche Krebshilfe (grant number 70110215, 70112047) and supported by medac. With respect to data obtained in the ABC-02 trial, the combination of cisplatin and gemcitabine for 24 weeks as investigational treatment was selected. Based on adjuvant trials in pancreatic cancer (e.g. ESPAC IV) with a comparable postoperative recovery time, inclusion of patients within a maximum interval of 16 weeks between surgery and start of CTx was chosen. Gemcitabine and cisplatin has a relevantly higher cumulative dose of gemcitabine 18 vs. 12 applications and may thus be of increased efficacy compared to the gemcitabine/oxaliplatin regimen applied in the PRODIGE 12 trial. 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 needs to be established. Therefore, the ACTICCA trial will be 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 will be 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.

Clinical Study Identifier: NCT02170090

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Neil Merrett

Bankstown Hospital
Bankstown, Australia
  Connect »

Jenny Shannon, Dr

Nepean Hospital Cancer Care
Kingswood, Australia
  Connect »

N N

Royal North Shore Hospital
St Leonards, Australia
  Connect »

Antonio Bonaventura, Dr

Calvary Mater Newcastle
Waratah, Australia
  Connect »

Suresh Varma, Dr

Townsville Hospital
Douglas, Australia
  Connect »

Matthew Burge

Royal Brisbane and Women's Hospital
Herston, Australia
  Connect »

Chris Karapetis

Flinders Medical Centre
Bedford Park, Australia
  Connect »

Guy Van Hazel, Dr

Sir Charles Gairdner Hospital
Nedlands, Australia
  Connect »

Thomas Gruenberger, Prof

Rudolfstift Hospital
Vienna, Austria
  Connect »

Lars Henrik Jensen, Dr

Vejle Hospital
Vejle, Denmark
  Connect »

Tom Luedde, MD

University Medical Center Aachen
Aachen, Germany
  Connect »

Marianne Sinn, MD

Charite Berlin
Berlin, Germany
  Connect »

Kalff, Prof

University Medical Center Bonn
Bonn, Germany
  Connect »

Alexander Stein

University Hospital Cologne
Cologne, Germany
  Connect »

Gunnar Folprecht, MD

University Medical Center Carl Gustav Carus
Dresden, Germany
  Connect »

W T Knoefel, Prof

University Medical Center Duesseldorf
Duesseldorf, Germany
  Connect »

Stefan Kasper, MD

University Medical Center Essen
Essen, Germany
  Connect »

Wolf Bechstein, Prof

University of Frankfurt
Frankfurt, Germany
  Connect »

Volker Brass, MD

University Medical Center Freiburg
Freiburg, Germany
  Connect »

Alexander Stein, MD

University Medical Center Hamburg-Eppendorf
Hamburg, Germany
  Connect »

Arndt Vogel, Prof

University of Hannover
Hannover, Germany
  Connect »

Christoph Springfeld, MD

University of Heidelberg
Heidelberg, Germany
  Connect »

Frank Lammert, Prof

University of Saarland
Homburg, Germany
  Connect »

Udo Lindig, MD

University Medical Center Jena
Jena, Germany
  Connect »

Thomas Becker, Prof

University Hospital Schleswig-Holstein Campus Kiel
Kiel, Germany
  Connect »

Arndt Weinmann, MD

Johannes Gutenberg University of Mainz
Mainz, Germany
  Connect »

Nadine Schulte, MD

University of Mannheim
Mannheim, Germany
  Connect »

Markus Rentsch

University of Munich Grosshadern
Munich, Germany
  Connect »

Elisabeth Schnoy, MD

University of Regensburg
Regensburg, Germany
  Connect »

Ruben Plentz, MD

University Medical Center Tuebingen
Tuebingen, Germany
  Connect »

Thomas Ettrich, MD

University of Ulm
Ulm, Germany
  Connect »

Volker Kunzmann, Prof

University Medical Center
Wuerzburg, Germany
  Connect »

Heinz-Josef Klümpen

Academic Medical Center
Amsterdam, Netherlands
  Connect »

G.A.P. Hospers, Prof.

UMC Groningen Cancer Center
Groningen, Netherlands
  Connect »

Judith de Vos

University Medical Center
Maastricht, Netherlands
  Connect »

Ferry Eskens

Erasmus Medisch Centrum
Rotterdam, Netherlands
  Connect »

Nadja Haj Mohammad, MD

Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
  Connect »

Yuk Ting Ma, Dr

Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
  Connect »

Tamas Hikish, Dr

Royal Bournemouth Hospital
Bournemouth, United Kingdom
  Connect »

Alexander Stein

Bristol Haematology and Oncology Centre
Bristol, United Kingdom
  Connect »

Pippa Corrie, Dr

Addenbrooke's Hospital Cambridge
Cambridge, United Kingdom
  Connect »

Hilary Williams, Dr

Velindre Hospital Cardiff
Cardiff, United Kingdom
  Connect »

Alexander Stein

Western General Hospital Edinburgh
Edinburgh, United Kingdom
  Connect »

Alexander Stein

Beatson West of Scotland Cancer Centre Glasgow
Glasgow, United Kingdom
  Connect »

Ulrike Dernedde, Dr

James Paget University Hospitals
Great Yarmouth, United Kingdom
  Connect »

Tony Dhillon, Dr

Royal Surrey County Hospital Guildford
Guildford, United Kingdom
  Connect »

Andrew Jackson, Dr

Hampshire Hospitals NHS Foundation Trust
Hampshire, United Kingdom
  Connect »

Emma Rathbone, Dr

Huddersfield Royal Infirmary
Huddersfield, United Kingdom
  Connect »

Alexander Stein

St James's University Hospital Leeds
Leeds, United Kingdom
  Connect »

Harpreet Wasan, Dr

Hammersmith Hospital London
London, United Kingdom
  Connect »

Roopinder Gillmore, Dr

Royal Free Hospital London
London, United Kingdom
  Connect »

Alexander Stein

St Bartholomew's Hospital London
London, United Kingdom
  Connect »

Alexander Stein

St Thomas's Hospital London
London, United Kingdom
  Connect »

John Bridgewater, Prof

University College London Hospital
London, United Kingdom
  Connect »

Justin Waters, Dr

Maidstone Hospital
Maidstone, United Kingdom
  Connect »

Richard Hubner, Dr

Christie Hospital Manchester
Manchester, United Kingdom
  Connect »

Daniel Palmer, Prof

Clatterbridge Cancer Centre Merseyside
Merseyside, United Kingdom
  Connect »

Alexander Stein

Freeman Hospital Newcastle
Newcastle, United Kingdom
  Connect »

Arvind Arora, Dr

Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
  Connect »

Geoffrey Cogill, Dr

Derriford Hospital Plymouth
Plymouth, United Kingdom
  Connect »

Suzanne Darby, Dr

Weston Park Hospital Sheffield
Sheffield, United Kingdom
  Connect »

Charlotte Rees, Dr

Southampton General Hospital
Southampton, United Kingdom
  Connect »