Anatomical Resection of liver MetAstases iN patIents with RAS-mutated colorectal cancer

Not Applicable

Recruiting

• Conditions: Colorectal liver metastases

• Registration Number: DRKS00023792
• Lead Sponsor: Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität DresdenAnstalt des öffentlichen Rechts des Freistaates Sachsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.