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

NCT ID: NCT04678583

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2027-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Colorectal Liver Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, patient and observer-blinded, confirmatory trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A - Anatomical resection

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

Group Type EXPERIMENTAL

Resection of colorectal liver metastases

Intervention Type PROCEDURE

Comparison of two liver surgery methods

B - Non-anatomical resection

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

Group Type ACTIVE_COMPARATOR

Resection of colorectal liver metastases

Intervention Type PROCEDURE

Comparison of two liver surgery methods

Interventions

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Resection of colorectal liver metastases

Comparison of two liver surgery methods

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Cancer Research Center

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jürgen Weitz, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

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

Nuh Rahbari, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Allgemein- und Viszeralchirugie, University Hospital Ulm

Locations

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

Mannheim, Baden-Wurttemberg, Germany

Site Status RECRUITING

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

Dresden, Saxony, Germany

Site Status RECRUITING

Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach

Ansbach, , Germany

Site Status RECRUITING

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

Augsburg, , Germany

Site Status RECRUITING

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

Berlin, , Germany

Site Status RECRUITING

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

Bonn, , Germany

Site Status RECRUITING

Surgical Clinic, Municipal Hospital Braunschweig gGmbH

Braunschweig, , Germany

Site Status RECRUITING

Cancer Center, Helios Amper-Hospital Dachau

Dachau, , Germany

Site Status RECRUITING

Surgical Clinic, Dortmund Hospital

Dortmund, , Germany

Site Status RECRUITING

Clinic for General and Visceral Surgery, Municipal Hospital Dresden

Dresden, , Germany

Site Status RECRUITING

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

Düsseldorf, , Germany

Site Status RECRUITING

Surgical Clinic, University Hospital Erlangen

Erlangen, , Germany

Site Status RECRUITING

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

Frankfurt, , Germany

Site Status RECRUITING

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

Freiburg im Breisgau, , Germany

Site Status RECRUITING

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

Giessen, , Germany

Site Status RECRUITING

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

Göttingen, , Germany

Site Status RECRUITING

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

Greifswald, , Germany

Site Status RECRUITING

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

Halle, , Germany

Site Status RECRUITING

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

Hamburg, , Germany

Site Status RECRUITING

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

Hamburg, , Germany

Site Status RECRUITING

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

Hanover, , Germany

Site Status RECRUITING

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

Hanover, , Germany

Site Status RECRUITING

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

Heidelberg, , Germany

Site Status RECRUITING

General Visceral and Vascular Surgery, Jena University Medical Center

Jena, , Germany

Site Status RECRUITING

Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus

Lübeck, , Germany

Site Status RECRUITING

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

Magdeburg, , Germany

Site Status RECRUITING

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

Mainz, , Germany

Site Status RECRUITING

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

Marburg, , Germany

Site Status RECRUITING

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

Munich, , Germany

Site Status RECRUITING

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

München, , Germany

Site Status RECRUITING

Department of Surgery, University Hospital rechts der Isar

München, , Germany

Site Status RECRUITING

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

Münster, , Germany

Site Status RECRUITING

University Hospital for General and Visceral Surgery, Oldenburg Hospital

Oldenburg, , Germany

Site Status WITHDRAWN

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

Tübingen, , Germany

Site Status RECRUITING

Clinic for General and Visceral Surgery, Ulm University Medical Center

Ulm, , Germany

Site Status RECRUITING

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

Wuppertal, , Germany

Site Status RECRUITING

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

Würzburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jürgen Weitz, Prof Dr med

Role: CONTACT

+49-(0)351 458 4850

Facility Contacts

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Jürgen Weitz, Prof Dr med

Role: primary

Secretary

Role: backup

+49-(0)351 458 4850

Other Identifiers

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VTG-08

Identifier Type: -

Identifier Source: org_study_id

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