Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases
About this study
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.
- Condition
- Colorectal Cancer, Colorectal Neoplasms Malignant, Liver Metastasis Colon Cancer, Liver Metastases
- Tested
- Staged resection, Simultaneous resection
- Sponsor
- Oslo University Hospital
Who can join
- Age
- 18 to 80 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Maximum age: 80 years
- Study condition: Colorectal Cancer, Colorectal Neoplasms Malignant, Liver Metastasis Colon Cancer, Liver Metastases
- 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).
Exclusion 11
- Unresectable primary tumor.
- Locally advanced primary tumor (T4).
- Primary tumor in the lower rectum with indication for abdominoperineal resection.
- Acute or imminent bowel obstruction.
- Perforation or major bleeding from the primary tumor.
- Pre-treatment of the primary tumor with a colon stent.
- Liver resection requiring resection of more than 2 adjacent segments (Couinaud).
- Liver metastases planned treated with irreversible electroporation (IRE).
- Non-resectable lung metastases.
- Metastases outside of liver (besides resectable lung metastases).
- Eastern Cooperative Oncology Group (ECOG) Performance status ≥ 3.
Where
1 site, 1 recruiting
Oslo University Hospital
Oslo, Norway
Contact
-
Sheraz Yaqub, MD PhD
+47-23073296 shya@ous-hf.no
-
Frida B Hansen
Potential match only. Final eligibility is determined by the study team.