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

NCT04678583 | Recruiting

• 1 other identifier: VTG-08
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 37

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).

Conditions

Colorectal Liver Metastasis

Outcome Measures

Primary Outcomes (1)

• Intrahepatic disease-free survival (iDFS)

  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.

  24 months

Secondary Outcomes (25)

• Assessment of additional oncological and perioperative outcomes: Intraoperative blood loss [mL]

  During surgery

• Assessment of additional oncological and perioperative outcomes: Operating time [min]

  During surgery

• Assessment of additional oncological and perioperative outcomes: Transfusion of blood, transfused packed red blood cells (PRBC), fresh frozen plasma (FFP) and / or platelet concentrate (PC) [units]

  48 hours after surgery

• Assessment of additional oncological and perioperative outcomes: Duration of postoperative hospital stay [days]

  At day of discharge, assessed up to 90 days

• Assessment of additional oncological and perioperative outcomes: Duration of postoperative intermediate/intensive care unit stay [days]

  At day of discharge, assessed up to 90 days

Study Arms (2)

A - Anatomical resection

EXPERIMENTAL

removal of the entire, tumor-bearing liver segment(s)

Procedure: Resection of colorectal liver metastases

B - Non-anatomical resection

ACTIVE COMPARATOR

metastasectomy with a margin of healthy liver tissue irrespective of segmental borders

Procedure: Resection of colorectal liver metastases

Interventions

Resection of colorectal liver metastases PROCEDURE

Comparison of two liver surgery methods

A - Anatomical resection; B - Non-anatomical resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• German Cancer Research Center: collaborator

Study Sites (37)

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

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

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

Dresden, Saxony, 01307, 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 Officials

• Jürgen Weitz, Prof Dr med

  Department of Gastrointestinal-, Thoracic and Vascular Surgery, University Hospital CGC

  PRINCIPAL INVESTIGATOR

• Nuh Rahbari, Prof Dr med

  Allgemein- und Viszeralchirugie, University Hospital Ulm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jürgen Weitz, Prof Dr med

CONTACT

+49-(0)351 458 4850; juergen.weitz@ukdd.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, patient and observer-blinded, confirmatory trial

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: December 22, 2020
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

DE (37)