Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy or in Front of Radical Resection of BTC (ICC/ECC) - A Phase III Study of the German Registry of Incidental Gallbladder Carcinoma Platform (GR) - The AIO/ CALGP/ ACO- GAIN-Trial - (GAIN)
Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection
versus immediate radical liver resection alone with or without adjuvant chemotherapy in
incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of
radical resection of BTC (ICC/ECC)
The aim of the study is to investigate whether induction chemotherapy followed by radical
re-resection (and - if possible - postoperative chemotherapy) in incidental gallbladder
carcinoma (IGBC) or in front radical resection in biliary tract cancer (BTC) (intrahepatic
cholangiocarcinoma (ICC)/ extrahepatic cholangiocarcinoma (ECC)) prolongs overall survival
without impaired quality of life compared to immediate radical surgery alone with or without
adjuvant chemotherapy (investigator's choice) in patients with IGBC, or BTC (ICC/ECC). One of
the most important secondary objectives is to raise awareness for the necessity of a radical
second surgery as well as to improve the adherence to the treatment guidelines in IGBC.
Further secondary objectives are safety and tolerability of the treatment as well as quality
Incidental Gallbladder Carcinoma, Biliary Tract Cancer
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