Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer

Despite increasing application and success of personalized treatment in medical oncology, little progress has been made in personalized surgical cancer therapy. The ARMANI trial presents the first prospective, randomized trial to evaluate effectiveness and safety of molecular-guided resection in patients with colorectal liver metastasis (CRLM). While CRLM might be removed independently of the liver's segmental borders, retrospective data favor anatomic resections in the subgroup of patients with a mutation in the RAS oncogene. Therefore, the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated CRLM. The trial will be carried out among 11 high-volume centers of hepato-biliary surgery in Germany. A total of 220 patients will be enrolled and randomized in a 1:1 ratio to undergo an AR vs. NAR. The primary endpoint is intrahepatic disease-free survival (iDFS). In addition, the study will provide important data on perioperative outcomes and quality of life for both surgical techniques. Given the trend among liver surgeons to aim for parenchymal-sparing operations to preserve liver parenchyma, a positive trial will be practice changing and present the first piece of high-level evidence on benefits of personalized surgical therapy guided by the tumor's mutational profile in patients with CRLM.

• Assessment of additional oncological and perioperative outcomes: Intraoperative blood loss [mL] [Срок оценки: During surgery]
• Assessment of additional oncological and perioperative outcomes: Operating time [min] [Срок оценки: During surgery]
• Assessment of additional oncological and perioperative outcomes: Transfusion of blood, transfused packed red blood cells (PRBC), fresh frozen plasma (FFP) and / or platelet concentrate (PC) [units] [Срок оценки: 48 hours after surgery]
• Assessment of additional oncological and perioperative outcomes: Duration of postoperative hospital stay [days] [Срок оценки: At day of discharge, assessed up to 90 days]
• Assessment of additional oncological and perioperative outcomes: Duration of postoperative intermediate/intensive care unit stay [days] [Срок оценки: At day of discharge, assessed up to 90 days]
• Assessment of additional oncological and perioperative outcomes: Frequency of peri-operative morbidity after resection [Срок оценки: 90 days after surgery]
• Assessment of additional oncological and perioperative outcomes: Kind of peri-operative morbidity after resection [Срок оценки: 90 days after surgery]
• Assessment of additional oncological and perioperative outcomes: 90-day mortality [Срок оценки: 90 days after surgery]
• Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Platelet count [Срок оценки: pre-operatively, 5 days after surgery]
• Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Alanine-aminotransferase [Срок оценки: pre-operatively, 5 days after surgery]
• Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: aspartate-aminotransferase [Срок оценки: pre-operatively, 5 days after surgery]
• Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Gamma-glutamyl transferase [Срок оценки: pre-operatively, 5 days after surgery]