About this trial
The goal of this observational study is to learn about treatment outcomes, quality of life, and healthcare costs in patients with colorectal cancer who have liver metastases detected at the same time as their primary tumor (synchronous colorectal liver metastases, CRLM). The main questions it aims to answer are:
Do patients who undergo simultaneous removal of both the bowel tumor and liver metastases in one operation differ in their ability to complete the intended treatment compared to patients who undergo staged operations (bowel first or liver first)? Does the choice of surgical strategy affect quality of life and healthcare costs?
Patients with synchronous CRLM discussed at a multidisciplinary team meeting at participating Swedish university hospitals will be followed prospectively for up to 5 years. Treatment is not influenced by the study - all surgical decisions are made as part of routine clinical care. Patients in the quality-of-life sub-study will complete validated questionnaires (EORTC QLQ-C30, QLQ-LM21, and QLQ-CR29) at multiple time points from diagnosis through 36 months. Healthcare costs and health literacy will also be assessed in parallel sub-studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Histologically proven colorectal cancer
Radiological evidence of liver metastases (contrast-enhanced CT or MRI), detected prior to resection of the primary colorectal tumor
Primary colorectal tumor (colon or rectum) in situ at time of inclusion
Disqualifiers
Unable to give informed consent (Studies 4-6 only; opt-out applies to Study 3)
Untreatable extrahepatic metastases at the discretion of the MDT
Not scheduled for curative resection of both the primary tumor and liver metastases
Emergency resection of the primary tumor performed prior to MDT referral
Trial population
Patients with synchronous colorectal liver metastases (CRLM) discussed at a hepatobiliary and/or colorectal multidisciplinary team (MDT) meeting at participating Swedish university hospitals. The population includes all patients in whom curative treatment of both the primary colorectal tumor and liver metastases is considered feasible by the MDT, irrespective of WHO performance status, suitability for chemotherapy, prior history of malignancy, or the presence of treatable extrahepatic disease. Patients are identified consecutively at MDT meetings.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Failure to Return to Intended Oncological Treatment (RIOT)
The proportion of patients who do not complete their planned surgical treatment pathway, and the reasons for failure. In staged resections, this most commonly occurs when disease progression during the interval between operations renders the second operation unfeasible.
Secondary outcomes
Overall Survival
Survival assessed from the date of diagnosis of the primary colorectal tumor
Recurrence-Free Survival
Defined as the absence of tumor or metastases on a CT scan undertaken after completion of all intended treatment (both liver and primary tumor resection).
90-Day Mortality
Death from any cause within 90 days of the first surgical procedure.
30-Day Readmission
Unplanned hospital readmission within 30 days of any surgical procedure.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: