Liver-First, Bowel-First, or Simultaneous Resection for Synchronous Colorectal Liver Metastases: … (NCT07564284) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Liver-First, Bowel-First, or Simultaneous Resection for Synchronous Colorectal Liver Metastases: Outcomes, Quality of Life, and Cost-Effectiveness
200 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Discussed at a hepatobiliary and/or colorectal multidisciplinary team (MDT) meeting
* Planned curative treatment of both the primary colorectal tumor AND the liver metastases (by resection, ablation, or transplantation)
* Planned curative treatment of any extrahepatic disease, if present
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Failure to Return to Intended Oncological Treatment (RIOT)
Timeframe: From date of MDT discussion to completion of intended treatment, assessed up to 24 months.