Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Biliary Tract Cancer
Conditions
Cholangiocarcinoma - Gall Bladder Carcinoma
Conditions: official terms
Carcinoma - Cholangiocarcinoma - Gallbladder Neoplasms - Urinary Bladder Neoplasms
Conditions: Keywords
adjuvant chemotherapy, cholangocarcinoma, muscle invasive gall bladder carcinoma, translational research, multidisciplinary, AIO, DGAV, DGVS
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine Type: Drug
Name: Cisplatin Type: Drug
Name: Observation Type: Other
Overall Status
Recruiting
Summary
This is a multicentre, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. observation alone 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 110215) and supported my 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. Due to the different prognosis and treatment susceptibility of muscle invasive carcinoma, two separate cohorts for CCA and GBCA were included to capture the expected treatment effects. Randomization will be stratified for lymph node status for both cohorts and localization for CCA. The primary endpoint is DFS and secondary endpoints include OS, safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence. In both cohorts, randomization will be 1:1 with adjuvant CTx for 24 weeks and imaging every 12 weeks in the experimental arm and observation only in the control arm.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 cholangicarcinoma 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
University Medical Center Aachen
Aachen, Germany
Status: Recruiting
Contact: Tom Luedde, MD - 0241 8035609 - tluedde@ukaachen.de
Charite Berlin
Berlin, Germany
Status: Recruiting
Contact: Marianne Sinn, MD - 030 450 55 3222 - marianne.sinn@charite.de
University Medical Center Bonn
Bonn, Germany
Status: Not yet recruiting
Contact: Kalff, Prof - 0049 228 287 15327 - kalff@uni-bonn.de
University Medical Center Carl Gustav Carus
Dresden, Germany
Status: Not yet recruiting
Contact: Gunnar Folprecht, MD - 0351 458 4794 - gunnar.folprecht@uniklinikum-dresden.de
University Medical Center Essen
Essen, Germany
Status: Recruiting
Contact: Stefan Kasper, MD - 0049 201 723 2039 - stefan.kasper@uk-essen.de
University of Frankfurt
Frankfurt, Germany
Status: Recruiting
Contact: Stefan Zeuzem, Prof - zeuzem@em.uni-frankfurt.de
University Medical Center Freiburg
Freiburg, Germany
Status: Recruiting
Contact: Volker Brass, MD - 0049761 270 34010 - volker.brass@uniklinik-freiburg.de
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Status: Recruiting
Contact: Alexander Stein, MD - 004940741056882 - a.stein@uke.de
University of Hannover
Hannover, Germany
Status: Recruiting
Contact: Arndt Vogel, Prof - vogel.arndt@mh-hannover.de
University of Heidelberg
Heidelberg, Germany
Status: Recruiting
Contact: K H Weiss, MD - Karl-Heinz.Weiss@med.uni-heidelberg.de
University of Saarland
Homburg, Germany
Status: Not yet recruiting
Contact: Frank Lammert, Prof - frank.lammert@uks.eu
University Medical Center Jena
Jena, Germany
Status: Recruiting
Contact: Udo Lindig, MD - 0049 3641 9324586 - udo.lindig@med.uni-jena.de
University of Leipzig
Leipzig, Germany
Status: Not yet recruiting
Contact: Albrecht Hoffmeister, MD - albrecht.hoffmeister@medizin.uni-leipzig.de
Johannes Gutenberg University of Mainz
Mainz, Germany
Status: Recruiting
Contact: Arndt Weinmann, MD - arndt.weinmann@unimedizin-mainz.de
University of Mannheim
Mannheim, Germany
Status: Recruiting
Contact: Nadine Schulte, MD - nadine.schulte@umm.de
University of Munich Grosshadern
Munich, Germany
Status: Recruiting
Contact: Markus Rentsch - mrentsch@med.uni-muenchen.de
University of Regensburg
Regensburg, Germany
Status: Not yet recruiting
Contact: Elisabeth Schnoy, MD - elisabeth.schnoy@ukr.de
University Medical Center Tuebingen
Tuebingen, Germany
Status: Recruiting
Contact: Ruben Plentz, MD - 07071 2984457 - ruben.plentz@med.uni-tuebingen.de
University of Ulm
Ulm, Germany
Status: Recruiting
Contact: Thomas Ettrich, MD - thomas.ettrich@uniklinik-ulm.de
University Medical Center
Wuerzburg, Germany
Status: Recruiting
Contact: Volker Kunzmann, Prof - 0049931 201 31042 - kunzmann_v@medizin.uni-wuerzburg.de
Academic Medical Center
Amsterdam, Netherlands
Status: Recruiting
Contact: Heinz-Josef Klümpen - h.klumpen@amc.uva.nl
UMC Groningen Cancer Center
Groningen, Netherlands
Status: Recruiting
Contact: G.A.P. Hospers, Prof. - g.a.p.hospers@umcg.nl
University Medical Center
Maastricht, Netherlands
Status: Recruiting
Contact: Judith de Vos - judith.de.vos@mumc.nl
Erasmus Medisch Centrum
Rotterdam, Netherlands
Status: Recruiting
Contact: Ferry Eskens - f.eskens@erasmusmc.nl
Start Date
April 2014
Completion Date
April 2022
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Source
Universitätsklinikum Hamburg-Eppendorf
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page