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

Technische Universität Dresden

Status: Enrolling

Conditions: Colorectal Liver Metastasis

Treatments: Procedure: Resection of colorectal liver metastases

Study type: Interventional

Funder types: Other

Identifiers

NCT04678583

VTG-08

Details and patient eligibility

About

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).

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

240 participants in 2 patient groups

A - Anatomical resection

Experimental group

Description:

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

Treatment:

Procedure: Resection of colorectal liver metastases

B - Non-anatomical resection

Active Comparator group

Description:

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

Treatment:

Procedure: Resection of colorectal liver metastases