Surgery for liver metastases in patients with RAS-mutated colorectal cancer

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

This study is testing if a specific type of liver surgery can help people with RAS-mutated colorectal cancer live longer and healthier after their treatment compared to a different type of surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Technische Universität Dresden (Academic / other)
• Locations: 37 sites (Mannheim, Baden-Wurttemberg and 36 other locations)
• Trial ID: NCT04678583 on ClinicalTrials.gov

What this trial studies

The ARMANI trial aims to evaluate whether anatomic resection (AR) of colorectal liver metastases (CRLM) leads to better long-term outcomes compared to non-anatomical resection (NAR) in patients with RAS mutations. This prospective, randomized trial will enroll 220 patients across 11 high-volume surgical centers in Germany, assigning them to either AR or NAR in a 1:1 ratio. The primary endpoint is intrahepatic disease-free survival (iDFS), and the study will also assess perioperative outcomes and quality of life. This trial represents a significant step towards personalized surgical therapy based on tumor genetics.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with colorectal cancer exhibiting RAS mutations and liver metastases suitable for surgical resection.

Not a fit: Patients with extrahepatic metastases or those requiring staged liver resections are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved long-term survival and quality of life for patients with RAS-mutated colorectal liver metastases.

How similar studies have performed: While personalized treatment in medical oncology has advanced, this trial is among the first to rigorously test personalized surgical approaches for this specific patient population.

Eligibility criteria

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 Criteria:

* Extrahepatic metastases
* Planned staged liver resection (e.g. two-stage hepatectomy)
* Diagnosis of another cancer \< 5 years prior to randomization Exceptions: curatively treated 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 the nature and extent of the clinical trial and its possible consequences

Where this trial is running

Mannheim, Baden-Wurttemberg and 36 other locations

• Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University — Mannheim, Baden-Wurttemberg, Germany (Recruiting)
• Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden — Dresden, Saxony, Germany (Recruiting)
• Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach — Ansbach, Germany (Recruiting)
• Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital — Augsburg, Germany (Recruiting)
• Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin — Berlin, Germany (Recruiting)
• Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn — Bonn, Germany (Recruiting)
• Surgical Clinic, Municipal Hospital Braunschweig gGmbH — Braunschweig, Germany (Recruiting)
• Cancer Center, Helios Amper-Hospital Dachau — Dachau, Germany (Recruiting)
• Surgical Clinic, Dortmund Hospital — Dortmund, Germany (Recruiting)
• Clinic for General and Visceral Surgery, Municipal Hospital Dresden — Dresden, Germany (Recruiting)
• Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf — Düsseldorf, Germany (Recruiting)
• Surgical Clinic, University Hospital Erlangen — Erlangen, Germany (Recruiting)
• Clinic for General, Visceral and Transplant Surgery, University Hospital Frankfurt, Goethe University Frankfurt am Main — Frankfurt, Germany (Recruiting)
• Department for General and Visceral Surgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg — Freiburg im Breisgau, Germany (Recruiting)
• JLU Gießen, Department for General, Visceral, Thoracic and Transplant Surgery — Giessen, Germany (Recruiting)
• Clinic for General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Georg-August-University — Göttingen, Germany (Recruiting)
• Clinic and Polyclinic for General Surgery, Department of Gastrointestinal, Thoracic and Vascular Surgery, University Greifswald, University Hospital Greifswald — Greifswald, Germany (Recruiting)
• University Hospital and Polyclinic for Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale) — Halle, Germany (Recruiting)
• Center for Surgical Medicine - Clinic and Polyclinic for General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
• Department of Liver, Bile Duct and Pancreas Surgery, University Department of surgery, Asklepios Klinik Barmbek — Hamburg, Germany (Recruiting)
• Clinic for General, Visceral and Minimally Invasive Surgery, KRH Clinic Siloah, Hannover — Hanover, Germany (Recruiting)
• Medizinische Hochschule Hannover, Department of General, Visceral and Transplant Surgery — Hanover, Germany (Recruiting)
• Department of General, Visceral and Transplantation Surgery, University of Heidelberg — Heidelberg, Germany (Recruiting)
• General Visceral and Vascular Surgery, Jena University Medical Center — Jena, Germany (Recruiting)
• Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus — Lübeck, Germany (Recruiting)
• University Department of General, Visceral, Vascular and Transplant Surgery, Faculty of Medicine, Otto von Guericke University Magdeburg — Magdeburg, Germany (Recruiting)
• Clinic for General, Visceral and Transplantation Surgery, University Medical Center of the Johannes Gutenberg-University Mainz — Mainz, Germany (Recruiting)
• Clinic for Visceral, Thoracic and Vascular Surgery, University Hospital Giessen and Marburg — Marburg, Germany (Recruiting)
• LMU Munich Hospital, Clinic for General, Visceral and Transplant Surgery — Munich, Germany (Recruiting)
• Department Hepato-Pancreato-Biliary Surgery, Barmherzige Brüder gGmbH of the Hospital Barmherzige Brüder Munich — München, Germany (Recruiting)
• Department of Surgery, University Hospital rechts der Isar — München, Germany (Recruiting)
• Clinic for General, Visceral and Transplant Surgery, University of Münster — Münster, Germany (Recruiting)
• University Hospital for General and Visceral Surgery, Oldenburg Hospital — Oldenburg, Germany (Withdrawn)
• Department of General, Visceral and Transplant Surgery, University of Tübingen, Comprehensive Cancer Center — Tübingen, Germany (Recruiting)
• Clinic for General and Visceral Surgery, Ulm University Medical Center — Ulm, Germany (Recruiting)
• General and Visceral Surgery, Helios University Medical Center Wuppertal, University Witten/Herdecke — Wuppertal, Germany (Recruiting)
• Department for General, Visceral, Transplant, Vascular and Pediatric Surgery, Julius-Maximilian-University Würzburg, University Hospital Würzburg — Würzburg, Germany (Recruiting)

Study contacts

• Principal investigator: Jürgen Weitz, Prof Dr med — Department of Gastrointestinal-, Thoracic and Vascular Surgery, University Hospital CGC
• Study coordinator: Jürgen Weitz, Prof Dr med

Conditions Colorectal Liver Metastasis