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

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)

INTRODUCTION

  • Org Study ID: ACTICCA-1
  • Secondary ID: 2012-005078-70, ACTRN12615001283561
  • NTC ID: NCT02170090
  • Sponsor: Universitätsklinikum Hamburg-Eppendorf

BRIEF SUMMARY


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 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.


  • Overall Status
    Recruiting
  • Start Date
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Disease free survival (DFS)

Primary Outcome 1 - Timeframe: Disease free survival rate at 24 months (DFSR@24)

CONDITION

  • Cholangiocarcinoma
  • Gall Bladder Carcinoma

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Henning Wege

Role: Principal Investigator

Affiliation: Universitätsklinikum Hamburg-Eppendorf

Overall Contact

Name: Henning Wege

Phone: 004940741056882

Email: a.stein@uke.de

LOCATION

Facility Status Contact
Facility: Bankstown Hospital
Bankstown, New South Wales
Australia
Status: Recruiting Contact:
Neil Merrett, Prof

neil.merrett@sswahs.nsw.gov.au
Facility: Nepean Hospital Cancer Care
Kingswood, New South Wales
Australia
Status: Recruiting Contact:
Jenny Shannon, Dr

jenny.shannon@health.nsw.gov.au
Facility: St. George Hospital
Kogarah, New South Wales
Australia
Status: Recruiting Contact:
Winston Liauw, Prof

winston.liauw@health.nsw.gov.au
Facility: Prince of Wales Hospital
Randwick, New South Wales
Australia
Status: Recruiting Contact:
David Goldstein, Prof

d.goldstein@unsw.edu.au
Facility: Calvary Mater Newcastle
Waratah, New South Wales
Australia
Status: Recruiting Contact:
Antonio Bonaventura, Dr

tony.bonaventura@calvarymater.org.au
Facility: Townsville Hospital
Douglas, Queensland
Australia
Status: Recruiting Contact:
Suresh Varma, Dr

suresh.varma@health.qld.gov.au
Facility: Royal Brisbane and Women's Hospital
Herston, Queensland
Australia
Status: Recruiting Contact:
Matthew Burge

matthew.burge@health.qld.gov.au
Facility: Princess Alexandra Hospital
Woolloongabba, Queensland
Australia
Status: Recruiting Contact:
David Barnes

david.barnes2@health.qld.gov.au
Facility: Flinders Medical Centre
Bedford Park, South Australia
Australia
Status: Recruiting Contact:
Chris Karapetis

c.karapetis@flinders.edu.au
Facility: Fiona Stanley Hospital Perth
Murdoch, Western Australia 6150
Australia
Status: Recruiting Contact:
David Ransom, Dr

david.ransom@health.wa.gov.au
Facility: Sir Charles Gairdner Hospital
Nedlands, Western Australia
Australia
Status: Recruiting Contact:
Guy Van Hazel, Dr

Guy.VanHazel@health.wa.gov.au
Facility: St. John of God
Subiaco, Western Australia 6008
Australia
Status: Recruiting Contact:
Andrew Dean, Dr

adean@wamo.net.au
Facility: Kaiser-Franz-Josef Hospital
Vienna, 1030
Austria
Status: Recruiting Contact:
Thomas Gruenberger, Prof

tgruenberger@icloud.com
Facility: Vejle Hospital
Vejle,
Denmark
Status: Recruiting Contact:
Lars Henrik Jensen, Dr

lars.henrik.Jensen@rsyd.dk
Facility: University Medical Center Aachen
Aachen,
Germany
Status: Recruiting Contact:
Tom Luedde, Prof

tluedde@ukaachen.de
Facility: Charite Berlin
Berlin,
Germany
Status: Recruiting Contact:
Jana Striefler, Dr

Facility: University Medical Center Carl Gustav Carus
Dresden,
Germany
Status: Recruiting Contact:
Gunnar Folprecht, Prof
0351 458 4794
gunnar.folprecht@uniklinikum-dresden.de
Facility: University Medical Center Essen
Essen,
Germany
Status: Recruiting Contact:
Stefan Kasper, Prof
0049 201 723 2039
stefan.kasper@uk-essen.de
Facility: University of Frankfurt
Frankfurt,
Germany
Status: Recruiting Contact:
Wolf Bechstein, Prof

wolf.bechstein@kgu.de
Facility: University Medical Center Freiburg
Freiburg,
Germany
Status: Recruiting Contact:
Steffen Heeg, Dr

steffen.heeg@uniklinik-freiburg.de
Facility: University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Germany
Status: Recruiting Contact:
Alexander Stein, PD

a.stein@uke.de
Facility: University of Hannover
Hannover,
Germany
Status: Recruiting Contact:
Arndt Vogel, Prof

vogel.arndt@mh-hannover.de
Facility: University of Heidelberg
Heidelberg,
Germany
Status: Recruiting Contact:
Christoph Springfeld, MD PD

Christoph.Springfeld@med.uni-heidelberg.de
Facility: University of Saarland
Homburg,
Germany
Status: Recruiting Contact:
Frank Lammert, Prof

frank.lammert@uks.eu
Facility: University Medical Center Jena
Jena,
Germany
Status: Recruiting Contact:
Udo Lindig, Dr
0049 3641 9324586
udo.lindig@med.uni-jena.de
Facility: University Hospital Schleswig-Holstein Campus Kiel
Kiel,
Germany
Status: Recruiting Contact:
Thomas Becker, Prof

thomas.becker@uksh.de
Facility: Johannes Gutenberg University of Mainz
Mainz,
Germany
Status: Recruiting Contact:
Arndt Weinmann, PD

arndt.weinmann@unimedizin-mainz.de
Facility: University of Mannheim
Mannheim,
Germany
Status: Recruiting Contact:
Nadine Schulte, Dr

nadine.schulte@umm.de
Facility: University of Munich Grosshadern
Munich,
Germany
Status: Recruiting Contact:
Markus Rentsch, Prof

Markus.Rentsch@med.uni-muenchen.de
Facility: University of Regensburg
Regensburg,
Germany
Status: Recruiting Contact:
Kilian Weigand, PD

kilian.weigand@ukr.de
Facility: University Medical Center Tuebingen
Tuebingen,
Germany
Status: Recruiting Contact:
Florian Kreth, Dr

florian.kreth@med.uni-tuebingen.de
Facility: University of Ulm
Ulm,
Germany
Status: Recruiting Contact:
Thomas Ettrich, Dr

thomas.ettrich@uniklinik-ulm.de
Facility: University Medical Center
Wuerzburg,
Germany
Status: Recruiting Contact:
Volker Kunzmann, Prof

kunzmann_v@medizin.uni-wuerzburg.de
Facility: Academic Medical Center
Amsterdam,
Netherlands
Status: Recruiting Contact:
Heinz-Josef Klümpen

h.klumpen@amc.uva.nl
Facility: University Medical Center
Maastricht,
Netherlands
Status: Recruiting Contact:
Judith de Vos

judith.de.vos@mumc.nl
Facility: Erasmus Medisch Centrum
Rotterdam,
Netherlands
Status: Recruiting Contact:
Bas Groot Koerkamp, Dr

B.GrootKoerkamp@erasmusmc.nl
Facility: Universitair Medisch Centrum Utrecht
Utrecht,
Netherlands
Status: Recruiting Contact:
Nadja Haj Mohammad, MD

N.HajMohammad@umcutrecht.nl
Facility: Hampshire Hospitals NHS Foundation Trust
Basingstoke,
United Kingdom
Status: Recruiting Contact:
Andrew Jackson, Dr

andrew.jackson@uhs.nhs.uk
Facility: Queen Elizabeth Hospital Birmingham
Birmingham,
United Kingdom
Status: Recruiting Contact:
Yuk Ting Ma, Dr

YukTing.Ma@uhb.nhs.uk
Facility: Royal Bournemouth Hospital
Bournemouth,
United Kingdom
Status: Recruiting Contact:
Tamas Hikish, Dr

Tamas.hikish@rbch.nhs.uk
Facility: Addenbrooke's Hospital Cambridge
Cambridge,
United Kingdom
Status: Recruiting Contact:
Pippa Corrie, Dr

pippa.corrie@addenbrookes.nhs.uk
Facility: Velindre Hospital Cardiff
Cardiff,
United Kingdom
Status: Recruiting Contact:
Hilary Williams, Dr

Hilary.Williams4@wales.nhs.uk
Facility: Western General Hospital Edinburgh
Edinburgh,
United Kingdom
Status: Recruiting Contact:
Alan Christie, Dr

alan.christie@nhslothian.scot.nhs.uk
Facility: Beatson West of Scotland Cancer Centre Glasgow
Glasgow,
United Kingdom
Status: Recruiting Contact:
Janet Graham, Dr

janet.graham@glasgow.ac.uk
Facility: James Paget University Hospitals
Great Yarmouth,
United Kingdom
Status: Recruiting Contact:
Ulrike Dernedde, Dr

ulrike.dernedde@jpaget.nhs.uk
Facility: Royal Surrey County Hospital Guildford
Guildford,
United Kingdom
Status: Recruiting Contact:
Tony Dhillon, Dr

tony.dhillon@nhs.net
Facility: Huddersfield Royal Infirmary
Huddersfield,
United Kingdom
Status: Recruiting Contact:
Emma Rathbone, Dr

emma.rathbone@cht.nhs.uk
Facility: Guy's and St Thomas's Hospital London
London,
United Kingdom
Status: Recruiting Contact:
Paul Ross, Dr

Paul.Ross@gstt.nhs.uk
Facility: Hammersmith Hospital London
London,
United Kingdom
Status: Recruiting Contact:
Christopher Coyle, Dr

christopher.coyle@imperial.nhs.uk
Facility: Royal Free Hospital London
London,
United Kingdom
Status: Recruiting Contact:
Roopinder Gillmore, Dr

rgillmore@nhs.net
Facility: University College London Hospital
London,
United Kingdom
Status: Recruiting Contact:
John Bridgewater, Prof

j.bridgewater@ucl.ac.uk
Facility: Maidstone Hospital
Maidstone,
United Kingdom
Status: Recruiting Contact:
Justin Waters, Dr

justin.waters@nhs.net
Facility: Christie Hospital Manchester
Manchester,
United Kingdom
Status: Recruiting Contact:
Richard Hubner, Dr

Richard.Hubner@christie.nhs.uk
Facility: Nottingham University Hospitals NHS Trust
Nottingham,
United Kingdom
Status: Recruiting Contact:
Arvind Arora, Dr

arvind.arora@nuh.nhs.uk
Facility: Churchill Hospital Oxford
Oxford,
United Kingdom
Status: Recruiting Contact:
Kinnari Patel, Dr

kinnari.patel@ouh.nhs.uk
Facility: Derriford Hospital Plymouth
Plymouth,
United Kingdom
Status: Recruiting Contact:
Geoffrey Cogill, Dr

geoffrey.cogill@nhs.net
Facility: Weston Park Hospital Sheffield
Sheffield,
United Kingdom
Status: Recruiting Contact:
Suzanne Darby, Dr

suzanne.darby@sth.nhs.uk
Facility: Southampton General Hospital
Southampton,
United Kingdom
Status: Recruiting Contact:
Charlotte Rees, Dr

charlotte.rees@uhs.nhs.uk
Facility: Clatterbridge Cancer Centre
Wirral,
United Kingdom
Status: Recruiting Contact:
Daniel Palmer, Prof

daniel.palmer@liverpool.ac.uk