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

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

NCT ID: NCT02170090

Condition: Cholangiocarcinoma
Gall Bladder Carcinoma

Conditions: Official terms:
Carcinoma
Cholangiocarcinoma
Urinary Bladder Neoplasms
Gallbladder Neoplasms
Gemcitabine
Capecitabine

Conditions: Keywords:
adjuvant chemotherapy
cholangiocarcinoma
muscle invasive gall bladder carcinoma
translational research
multidisciplinary
AIO, DGAV, DGVS

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Gemcitabine
Description: Gemcitabine 1000mg/m2
Arm group label: Gemcitabine plus Cisplatin

Intervention type: Drug
Intervention name: Cisplatin
Description: Cisplatin 25mg/m2
Arm group label: Gemcitabine plus Cisplatin

Intervention type: Drug
Intervention name: Capecitabine
Description: Capecitabine 1250mg/m2
Arm group label: Capecitabine

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.

Detailed description: The ACTICCA-1 investigator initiated trial is funded by the Deutsche Krebshilfe (grant number 70110215, 70112047). 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 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.

Criteria for eligibility:
Criteria:
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: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Bankstown Hospital

Address:
City: Bankstown
Country: Australia

Facility:
Name: Nepean Hospital Cancer Care

Address:
City: Kingswood
Country: Australia

Facility:
Name: St. George Hospital

Address:
City: Kogarah
Country: Australia

Facility:
Name: Prince of Wales Hospital

Address:
City: Randwick
Country: Australia

Facility:
Name: Calvary Mater Newcastle

Address:
City: Waratah
Country: Australia

Facility:
Name: Townsville Hospital

Address:
City: Douglas
Country: Australia

Facility:
Name: Royal Brisbane and Women's Hospital

Address:
City: Herston
Country: Australia

Facility:
Name: Princess Alexandra Hospital

Address:
City: Woolloongabba
Country: Australia

Facility:
Name: Flinders Medical Centre

Address:
City: Bedford Park
Country: Australia

Facility:
Name: Fiona Stanley Hospital Perth

Address:
City: Murdoch
Zip: 6150
Country: Australia

Facility:
Name: Sir Charles Gairdner Hospital

Address:
City: Nedlands
Country: Australia

Facility:
Name: St. John of God

Address:
City: Subiaco
Zip: 6008
Country: Australia

Facility:
Name: Kaiser-Franz-Josef Hospital

Address:
City: Vienna
Zip: 1030
Country: Austria

Facility:
Name: Vejle Hospital

Address:
City: Vejle
Country: Denmark

Facility:
Name: University Medical Center Aachen

Address:
City: Aachen
Country: Germany

Facility:
Name: Charite Berlin

Address:
City: Berlin
Country: Germany

Facility:
Name: University Medical Center Carl Gustav Carus

Address:
City: Dresden
Country: Germany

Facility:
Name: University Medical Center Essen

Address:
City: Essen
Country: Germany

Facility:
Name: Klinikum Esslingen

Address:
City: Esslingen
Country: Germany

Facility:
Name: University of Frankfurt

Address:
City: Frankfurt
Country: Germany

Facility:
Name: University Medical Center Freiburg

Address:
City: Freiburg
Country: Germany

Facility:
Name: University Medical Center Hamburg-Eppendorf

Address:
City: Hamburg
Zip: 20246
Country: Germany

Facility:
Name: University of Hannover

Address:
City: Hannover
Country: Germany

Facility:
Name: University of Heidelberg

Address:
City: Heidelberg
Country: Germany

Facility:
Name: University of Saarland

Address:
City: Homburg
Country: Germany

Facility:
Name: University Medical Center Jena

Address:
City: Jena
Country: Germany

Facility:
Name: Johannes Gutenberg University of Mainz

Address:
City: Mainz
Country: Germany

Facility:
Name: University of Mannheim

Address:
City: Mannheim
Country: Germany

Facility:
Name: University of Munich Grosshadern

Address:
City: Munich
Country: Germany

Facility:
Name: University of Regensburg

Address:
City: Regensburg
Country: Germany

Facility:
Name: University Medical Center Tuebingen

Address:
City: Tuebingen
Country: Germany

Facility:
Name: University of Ulm

Address:
City: Ulm
Country: Germany

Facility:
Name: University Medical Center

Address:
City: Wuerzburg
Country: Germany

Facility:
Name: Istituto Nazionale dei Tumori

Address:
City: Milano
Country: Italy

Facility:
Name: Ospedale San Raffaele

Address:
City: Milano
Country: Italy

Facility:
Name: Istituto Oncologico Veneto IRCCS

Address:
City: Padova
Zip: 35128
Country: Italy

Facility:
Name: Azienda Ospedaliero Medica 2 Universitaria

Address:
City: Pisa
Zip: 56126
Country: Italy

Facility:
Name: Fondazione Policlinico Gemelli, Roma

Address:
City: Rome
Country: Italy

Facility:
Name: Academic Medical Center

Address:
City: Amsterdam
Country: Netherlands

Facility:
Name: University Medical Center

Address:
City: Maastricht
Country: Netherlands

Facility:
Name: Erasmus Medisch Centrum

Address:
City: Rotterdam
Country: Netherlands

Facility:
Name: Universitair Medisch Centrum Utrecht

Address:
City: Utrecht
Country: Netherlands

Facility:
Name: Auckland Hospital

Address:
City: Auckland
Country: New Zealand

Facility:
Name: Hampshire Hospitals NHS Foundation Trust

Address:
City: Basingstoke
Country: United Kingdom

Facility:
Name: Queen Elizabeth Hospital Birmingham

Address:
City: Birmingham
Country: United Kingdom

Facility:
Name: Royal Bournemouth Hospital

Address:
City: Bournemouth
Country: United Kingdom

Facility:
Name: Bristol Haematology and Oncology Centre

Address:
City: Bristol
Country: United Kingdom

Facility:
Name: Addenbrooke's Hospital Cambridge

Address:
City: Cambridge
Country: United Kingdom

Facility:
Name: Velindre Hospital Cardiff

Address:
City: Cardiff
Country: United Kingdom

Facility:
Name: Western General Hospital Edinburgh

Address:
City: Edinburgh
Country: United Kingdom

Facility:
Name: Beatson West of Scotland Cancer Centre Glasgow

Address:
City: Glasgow
Country: United Kingdom

Facility:
Name: James Paget University Hospitals

Address:
City: Great Yarmouth
Country: United Kingdom

Facility:
Name: Royal Surrey County Hospital Guildford

Address:
City: Guildford
Country: United Kingdom

Facility:
Name: Princess Alexandra Hospital

Address:
City: Harlow
Country: United Kingdom

Facility:
Name: Huddersfield Royal Infirmary

Address:
City: Huddersfield
Country: United Kingdom

Facility:
Name: Guy's and St Thomas's Hospital London

Address:
City: London
Country: United Kingdom

Facility:
Name: Hammersmith Hospital London

Address:
City: London
Country: United Kingdom

Facility:
Name: Royal Free Hospital London

Address:
City: London
Country: United Kingdom

Facility:
Name: University College London Hospital

Address:
City: London
Country: United Kingdom

Facility:
Name: Maidstone Hospital

Address:
City: Maidstone
Country: United Kingdom

Facility:
Name: Christie Hospital Manchester

Address:
City: Manchester
Country: United Kingdom

Facility:
Name: Nottingham University Hospitals NHS Trust

Address:
City: Nottingham
Country: United Kingdom

Facility:
Name: Churchill Hospital Oxford

Address:
City: Oxford
Country: United Kingdom

Facility:
Name: Derriford Hospital Plymouth

Address:
City: Plymouth
Country: United Kingdom

Facility:
Name: Weston Park Hospital Sheffield

Address:
City: Sheffield
Country: United Kingdom

Facility:
Name: Southampton General Hospital

Address:
City: Southampton
Country: United Kingdom

Facility:
Name: Clatterbridge Cancer Centre

Address:
City: Wirral
Country: United Kingdom

Start date: April 2014

Completion date: April 2024

Lead sponsor:
Agency: Universitätsklinikum Hamburg-Eppendorf
Agency class: Other

Collaborator:
Agency: Deutsche Krebshilfe e.V., Bonn (Germany)
Agency class: Other

Collaborator:
Agency: Cancer Research UK
Agency class: Other

Collaborator:
Agency: Australasian Gastro-Intestinal Trials Group
Agency class: Other

Collaborator:
Agency: Dutch Cancer Society
Agency class: Other

Source: Universitätsklinikum Hamburg-Eppendorf

Record processing date: ClinicalTrials.gov processed this data on April 10, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02170090
http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.4_suppl.225
http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.4006