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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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
• Email: juergen.weitz@ukdd.de
• Phone: +49-(0)351 458 4850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.