Status:
RECRUITING
Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
German Cancer Research Center
Conditions:
Colorectal Liver Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04678583
Start Date
January 1 2021
End Date
December 1 2027
Last Update
June 13 2024
Active Locations (37)
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1
Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
Mannheim, Baden-Wurttemberg, Germany, 68167
2
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden, Saxony, Germany, 01307
3
Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach
Ansbach, Germany
4
Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital
Augsburg, Germany