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NCT06200831Recruiting

Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases

Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases - A Multicentre Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and/or ablation (RFA/MWA) at time of evaluation.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
13 Dec 2023
Start date
1 Jun 2024
Primary completion date
31 Dec 2029
Lead sponsor
Oslo University Hospital
NCT number
NCT06200831

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 1 Jun 2024 to the primary completion date, 31 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Primary tumor in the lower rectum with indication for abdominoperineal resection.
  • Liver resection requiring resection of more than 2 adjacent segments (Couinaud).
  • Liver metastases planned treated with irreversible electroporation (IRE).

Other illness

  • Perforation or major bleeding from the primary tumor.

Other

  • Unresectable primary tumor.
  • Locally advanced primary tumor (T4).
  • Acute or imminent bowel obstruction.
  • Pre-treatment of the primary tumor with a colon stent.
  • Non-resectable lung metastases.
  • Metastases outside of liver (besides resectable lung metastases).
  • Eastern Cooperative Oncology Group (ECOG) Performance status ≥ 3.

Who the study is looking for

  • Age 18-80 years old.
  • Both CRC and liver metastases in situ at time of evaluation.
  • Resectable primary tumor in the colon or upper rectum.
  • Less than 5 liver metastases, evaluated by the multidisciplinary tumor board meeting as possible to treat with surgical resection and/or ablation (RFA/MWA).

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oslo University Hospital
Coordinator of this site? Confirm its status
OsloNorwayRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.