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

Last updated: June 12, 2024
Sponsor: Technische Universität Dresden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Neoplasm Metastasis

Primary Biliary Cholangitis

Treatment

Resection of colorectal liver metastases

Clinical Study ID

NCT04678583
VTG-08
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Colorectal cancer with RAS mutation (KRAS or NRAS)

  • Colorectal liver metastases (single or multiple)

  • Planned R0 resection of liver metastases (and primary tumor, if present)

  • Anatomical and non-anatomical liver resection technically feasible

  • Male and female patients, age ≥ 18 years

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Extrahepatic metastases

  • Planned staged liver resection (e.g. two-stage hepatectomy)

  • Diagnosis of another cancer < 5 years prior to randomization Exceptions: curativelytreated in situ cervical cancer, curatively resected non-melanoma skin cancer

  • Expected lack of compliance

  • Addiction or other illnesses which do not allow the person concerned to assess thenature and extent of the clinical trial and its possible consequences

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Resection of colorectal liver metastases
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University

    Mannheim, Baden-Württemberg 68167
    Germany

    Active - Recruiting

  • Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach

    Ansbach,
    Germany

    Active - Recruiting

  • Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital

    Augsburg,
    Germany

    Active - Recruiting

  • Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin

    Berlin,
    Germany

    Active - Recruiting

  • Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn

    Bonn,
    Germany

    Active - Recruiting

  • Surgical Clinic, Municipal Hospital Braunschweig gGmbH

    Braunschweig,
    Germany

    Active - Recruiting

  • Cancer Center, Helios Amper-Hospital Dachau

    Dachau,
    Germany

    Active - Recruiting

  • Surgical Clinic, Dortmund Hospital

    Dortmund,
    Germany

    Active - Recruiting

  • Clinic for General and Visceral Surgery, Municipal Hospital Dresden

    Dresden,
    Germany

    Active - Recruiting

  • Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf

    Düsseldorf,
    Germany

    Active - Recruiting

  • Surgical Clinic, University Hospital Erlangen

    Erlangen,
    Germany

    Active - Recruiting

  • Clinic for General, Visceral and Transplant Surgery, University Hospital Frankfurt, Goethe University Frankfurt am Main

    Frankfurt,
    Germany

    Active - Recruiting

  • Department for General and Visceral Surgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg

    Freiburg,
    Germany

    Active - Recruiting

  • JLU Gießen, Department for General, Visceral, Thoracic and Transplant Surgery

    Gießen,
    Germany

    Active - Recruiting

  • Clinic and Polyclinic for General Surgery, Department of Gastrointestinal, Thoracic and Vascular Surgery, University Greifswald, University Hospital Greifswald

    Greifswald,
    Germany

    Active - Recruiting

  • Clinic for General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Georg-August-University

    Göttingen,
    Germany

    Active - Recruiting

  • University Hospital and Polyclinic for Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale)

    Halle (Saale),
    Germany

    Active - Recruiting

  • Center for Surgical Medicine - Clinic and Polyclinic for General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf

    Hamburg,
    Germany

    Active - Recruiting

  • Department of Liver, Bile Duct and Pancreas Surgery, University Department of surgery, Asklepios Klinik Barmbek

    Hamburg,
    Germany

    Active - Recruiting

  • Clinic for General, Visceral and Minimally Invasive Surgery, KRH Clinic Siloah, Hannover

    Hannover,
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover, Department of General, Visceral and Transplant Surgery

    Hannover,
    Germany

    Active - Recruiting

  • Department of General, Visceral and Transplantation Surgery, University of Heidelberg

    Heidelberg,
    Germany

    Active - Recruiting

  • General Visceral and Vascular Surgery, Jena University Medical Center

    Jena,
    Germany

    Active - Recruiting

  • Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus

    Lübeck,
    Germany

    Active - Recruiting

  • University Department of General, Visceral, Vascular and Transplant Surgery, Faculty of Medicine, Otto von Guericke University Magdeburg

    Magdeburg,
    Germany

    Active - Recruiting

  • Clinic for General, Visceral and Transplantation Surgery, University Medical Center of the Johannes Gutenberg-University Mainz

    Mainz,
    Germany

    Active - Recruiting

  • Clinic for Visceral, Thoracic and Vascular Surgery, University Hospital Giessen and Marburg

    Marburg,
    Germany

    Active - Recruiting

  • LMU Munich Hospital, Clinic for General, Visceral and Transplant Surgery

    Munich,
    Germany

    Active - Recruiting

  • Department Hepato-Pancreato-Biliary Surgery, Barmherzige Brüder gGmbH of the Hospital Barmherzige Brüder Munich

    München,
    Germany

    Active - Recruiting

  • Department of Surgery, University Hospital rechts der Isar

    München,
    Germany

    Active - Recruiting

  • Clinic for General, Visceral and Transplant Surgery, University of Münster

    Münster,
    Germany

    Active - Recruiting

  • University Hospital for General and Visceral Surgery, Oldenburg Hospital

    Oldenburg,
    Germany

    Site Not Available

  • Department of General, Visceral and Transplant Surgery, University of Tübingen, Comprehensive Cancer Center

    Tübingen,
    Germany

    Active - Recruiting

  • Clinic for General and Visceral Surgery, Ulm University Medical Center

    Ulm,
    Germany

    Active - Recruiting

  • General and Visceral Surgery, Helios University Medical Center Wuppertal, University Witten/Herdecke

    Wuppertal,
    Germany

    Active - Recruiting

  • Department for General, Visceral, Transplant, Vascular and Pediatric Surgery, Julius-Maximilian-University Würzburg, University Hospital Würzburg

    Würzburg,
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.