Spots Global Cancer Trial Database for Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer
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Trial Identification
Brief Title: Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer
Official Title: Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer
Study ID: NCT04678583
Conditions
Interventions
Study Description
Brief Summary: 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 colorectal liver metastasis (CRLM).
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Baden-Württemberg, Germany
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden, Dresden, Saxony, Germany
Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin, Berlin, , Germany
Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn, Bonn, , Germany
Surgical Clinic, Municipal Hospital Braunschweig gGmbH, Braunschweig, , Germany
Cancer Center, Helios Amper-Hospital Dachau, Dachau, , Germany
Clinic for General and Visceral Surgery, Municipal Hospital Dresden, Dresden, , Germany
Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf, Düsseldorf, , Germany
Surgical Clinic, University Hospital Erlangen, Erlangen, , Germany
Clinic for General, Visceral and Transplant Surgery, University Hospital Frankfurt, Goethe University Frankfurt am Main, Frankfurt, , Germany
Department for General and Visceral Surgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, , Germany
JLU Gießen, Department for General, Visceral, Thoracic and Transplant Surgery, Gießen, , Germany
Clinic and Polyclinic for General Surgery, Department of Gastrointestinal, Thoracic and Vascular Surgery, University Greifswald, University Hospital Greifswald, Greifswald, , Germany
Clinic for General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Georg-August-University, Göttingen, , Germany
University Hospital and Polyclinic for Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale), Halle (Saale), , Germany
Center for Surgical Medicine - Clinic and Polyclinic for General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf, Hamburg, , Germany
Department of Liver, Bile Duct and Pancreas Surgery, University Department of surgery, Asklepios Klinik Barmbek, Hamburg, , Germany
Medizinische Hochschule Hannover, Department of General, Visceral and Transplant Surgery, Hannover, , Germany
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, , Germany
General Visceral and Vascular Surgery, Jena University Medical Center, Jena, , Germany
Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus, Lübeck, , Germany
University Department of General, Visceral, Vascular and Transplant Surgery, Faculty of Medicine, Otto von Guericke University Magdeburg, Magdeburg, , Germany
Clinic for General, Visceral and Transplantation Surgery, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, , Germany
LMU Munich Hospital, Clinic for General, Visceral and Transplant Surgery, Munich, , Germany
Department Hepato-Pancreato-Biliary Surgery, Barmherzige Brüder gGmbH of the Hospital Barmherzige Brüder Munich, München, , Germany
Department of Surgery, University Hospital rechts der Isar, München, , Germany
Clinic for General, Visceral and Transplant Surgery, University of Münster, Münster, , Germany
University Hospital for General and Visceral Surgery, Oldenburg Hospital, Oldenburg, , Germany
Department of General, Visceral and Transplant Surgery, University of Tübingen, Comprehensive Cancer Center, Tübingen, , Germany
Clinic for General and Visceral Surgery, Ulm University Medical Center, Ulm, , Germany
General and Visceral Surgery, Helios University Medical Center Wuppertal, University Witten/Herdecke, Wuppertal, , Germany
Department for General, Visceral, Transplant, Vascular and Pediatric Surgery, Julius-Maximilian-University Würzburg, University Hospital Würzburg, Würzburg, , Germany
Contact Details
Name: Jürgen Weitz, Prof Dr med
Affiliation: Department of Gastrointestinal-, Thoracic and Vascular Surgery, University Hospital CGC
Role: PRINCIPAL_INVESTIGATOR
Name: Nuh Rahbari, Prof Dr med
Affiliation: Allgemein- und Viszeralchirugie, University Hospital Ulm
Role: PRINCIPAL_INVESTIGATOR
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