Klinische Studie

Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant(GAIN-trial)chemotherapy followed by liver resection versus liver resection alone in incidentally detected gallbladder carcinoma after simple cholecystectomy
Krankheitsentität(en) Gallenblase und Gallenweg
StudientypInterventionsstudiePhase III
Wesentliche EinschlusskriterienECOG performance status of 0, 1, or 2 5. Estimated life expectancy > 3 months 6. Female and male patients2 >18 years. 7. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures 8. No previous or preceding cytotoxic or targeted therapy for BTC or IGBC/GBC. 9. No previous malignancy within two years or concomitant malignancy, except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer
Wesentliche AusschlusskriterienKnown hypersensitivity against gemcitabine or cisplatin 2. Other known contraindications to gemcitabine or cisplatin 3. Clinically significant valvular defect 4. Past or current history of other malignancies not curatively treated and without evidence of disease for more than two years, except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgChirurgieStudienzentrale0941 9446736cotrialassociates(at)ukr.de