Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus radical liver resection alone in incidentally detected gallbladder carcinoma after simple cholecystectomy – A phase III study utilizing the German Registry

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Gallbladder carcinoma is the fifth most common neoplasm of the digestive tract, with an overall 5-year survival less than 5%. Due to the high frequency of laparoscopic cholecystectomies (LC), more incidental findings of gallbladder carcinomas are diagnosed. 2/3 of gallbladder carcinomas are so called incidental gallbladder carcinomas (IGBC). Cases IGBC in Germany are registered in theGerman Registry of Incidental Gallbladder Carcinoma (GR) overseen by the PI of the current trial. Stage-adjusted therapy includes second radical surgery of the liver and lymphadenectomy after LC (IRR -immediate radical re-resection). According to the S3 Guidelines in Germany this is recommended in cases of T2 and more advanced T-stages.There are two main problems in the curative management of IGBC. First of all, surgical management of gallbladder cancer remains inadequate [1-3]. Only 49% of T2-T3 carcinomas in the GR underwent the recommended IRR. In the study proposed, all trial patients will receive the IRR as mandatory part of the study design.Secondly, even after radical surgery, the outcome pT2-3 carcinomas – which notably represent the majority of the tumors, remains poor [3]. According to the GR, the 5-year OS of T2 is 38% with and 22% without IRR [7, 11]. In T3 it is 18% with and 12% without IRR [7, 11]. Cure of such patients by a pure surgical concept does not seem to be achievable. The encouraging results of multimodal concepts in esophagogastric-, rectal-, and other malignancies provide an additional rationale to use this kind of treatment in the early phase of IGBC management. Patients in the trial will be randomized to IRR +/- perioperative chemotherapy. Primary endpoint is OS.