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

NCT04678583 · tracked via the Priya Life Science Germany tracker

Sponsor

Technische Universität Dresden

Phase

Not applicable

Started

2021-01-01

Last updated

2024-06-13

Condition(s) studied

Colorectal Liver Metastasis

Investigational drug(s) / intervention(s)

Resection of colorectal liver metastases

Resection of colorectal liver metastases: Comparison of two liver surgery methods

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Intrahepatic disease-free survival (iDFS) — 24 months
Time from operation date to date of disease recurrence in the liver, followed up at intervals of three months for a maximum duration of 24 months or until death. Any new, solid lesion in the liver after resection of all CRLM that fulfils imaging criteria (CT, MRI) of a metastasis is counted as an iDFS event.

Trial sites (37)

Facility	City	Region	Status
Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University	Mannheim	Baden-Wurttemberg	Recruiting
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden	Dresden	Saxony	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04678583 on ClinicalTrials.gov ↗ ← All trials in Germany