Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resection of colorectal liver metastases.
- Who it may be relevant to
- Registry conditions: Colorectal Liver Metastasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Procedure Resection of colorectal liver metastases
Comparison of two liver surgery methods
Primary outcome measures
- Intrahepatic disease-free survival (iDFS) [Time frame: 24 months]
Secondary outcome measures (12)
- Assessment of additional oncological and perioperative outcomes: Intraoperative blood loss [mL] [Time frame: During surgery]
- Assessment of additional oncological and perioperative outcomes: Operating time [min] [Time frame: 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] [Time frame: 48 hours after surgery]
- Assessment of additional oncological and perioperative outcomes: Duration of postoperative hospital stay [days] [Time frame: 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] [Time frame: At day of discharge, assessed up to 90 days]
- Assessment of additional oncological and perioperative outcomes: Frequency of peri-operative morbidity after resection [Time frame: 90 days after surgery]
- Assessment of additional oncological and perioperative outcomes: Kind of peri-operative morbidity after resection [Time frame: 90 days after surgery]
- Assessment of additional oncological and perioperative outcomes: 90-day mortality [Time frame: 90 days after surgery]
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Platelet count [Time frame: pre-operatively, 5 days after surgery]
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Alanine-aminotransferase [Time frame: pre-operatively, 5 days after surgery]
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: aspartate-aminotransferase [Time frame: pre-operatively, 5 days after surgery]
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Gamma-glutamyl transferase [Time frame: pre-operatively, 5 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 37 centers
- Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, — Mannheim
- Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gu — Dresden
- Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach — Ansbach
- Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital — Augsburg
- Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, — Berlin
- Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hos — Bonn
- Surgical Clinic, Municipal Hospital Braunschweig gGmbH — Braunschweig
- Cancer Center, Helios Amper-Hospital Dachau — Dachau
- … and 29 more centers
Identifiers
NCT: NCT04678583 · VTG-08