Informationen und Ansprechpartner zu ACTICCA-1
Studienzentrum | Universitätstumorzentrum UTZ Klinik für Allgemein-, Viszeral- und Kinderchirurgie Moorenstr. 5 40225 Düsseldorf |
Direktor | Herr Univ.-Prof. Dr. med. Wolfram T. Knoefel Tel: 0211 81-17351 knoefel@uni-duesseldorf.de |
Ansprechpartner | Nicole Dietrichs, Studienassistentin Tel: 0211 81-07471 Nicole.Dietrichs@med.uni-duesseldorf.de
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Studienbeschreibung |
Gallenblasenkarzinom | ACTICCA-1 |
Studientitel | Eine multinationale, randomisierte Phase-III Studie zum Vergleich der adjuvanten Behandlung mit Gemcitabine und Cisplatin zur Standardtherapie (adjuvante Chemotherapie mit Capecitabine) nach kurativer Operation eines Gallenblasenkarzinoms
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 |
Kurzbeschreibung | 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 standard of care in the control arm. |
Betreffendes Organsystem | Gallenblasen-/Leberkrebs (Gallenblasenkarzinom, Leberkarzinom, Leberzellkrebs, Leberzellkarzinom, Hepatozelluläres Karzinom, HCC, Hepatobiliäre Tumore) |
Gesamte Studienbeschreibung | https://clinicaltrials.gov/ct2/show/NCT02170090 |
Studientyp | Therapie-Studie |
Studienstatus | Rekrutierung beendet (Teilnehmer werden nicht mehr aufgenommen) |
Für weitere Informationen - auch zu den Ein-/Auschlusskriterien - wenden Sie sich bitte an die oben genannten Ansprechpartner im Studienzentrum.