Optimizing Treatment of Synchronous Colorectal Liver Metastases - Creation of a Treatment Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Failure to Return to Intended Oncological Treatment (RIOT)
研究概览
简要总结
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.
详细描述
Background Patients with colorectal cancer who have liver metastases detected at the time of diagnosis (synchronous colorectal liver metastases, CRLM) require removal of both the bowel tumor and the liver metastases to achieve cure. Three surgical strategies are available: removing the bowel tumor first (bowel-first), removing the liver metastases first (liver-first), or removing both in a single operation (simultaneous resection). There is currently no consensus on which strategy is best, and practice varies considerably between hospitals and surgeons.
Study 1: Treatment Completion and Survival (Primary Study)
This prospective observational study enrolls all patients with synchronous CRLM discussed at a multidisciplinary team (MDT) meeting at participating Swedish university hospitals, where curative treatment of both the primary tumor and liver metastases is considered possible. Enrollment runs from May 2025 to May 2027, with follow-up continuing for up to 5 years.
Participation does not influence treatment in any way - all surgical and oncological decisions are made entirely according to routine clinical practice. Because the study is observational and involves no change to clinical care, an opt-out consent procedure is applied: patients are informed about the study and data collection, and are given four weeks to decline participation. If no objection is received, prospective data collection begins. Patients may withdraw at any time, and all their data will be deleted upon withdrawal.
The primary outcome is failure to Return to Intended Oncological Treatment (RIOT) - that is, the proportion of patients who do not complete their planned surgical treatment and the reasons for this. In a staged approach, this most commonly occurs when disease progression during the interval between the first and second operation renders the second operation unfeasible. Secondary outcomes include 3- and 5-year overall survival, recurrence-free survival, 90-day mortality, 30-day readmission, and complication severity assessed by the Comprehensive Complication Index and Clavien-Dindo classification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Synchronous colorectal liver metastases
Simultaneous Resection, Bowel-First Staged Resection, Liver-First Staged Resection
结局指标
主要结局
Failure to Return to Intended Oncological Treatment (RIOT)
时间窗: From date of MDT discussion to completion of intended treatment, assessed up to 24 months.
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.
次要结局
- Overall Survival(Time frame: 3 and 5 years from diagnosis)
- Recurrence-Free Survival(3 and 5 years from completion of treatment.)
- 90-Day Mortality(90 days from first surgery.)
- 30-Day Readmission(30 days from each surgical procedure.)
- Major complications(30 and 90 days from each surgical procedure)
- Full Treatment Completion(From MDT discussion to completion of intended treatment, assessed up to 24 months.)
- Health-Related Quality of Life (Study 2)(At inclusion, then at multiple time points through 36 months after completion of surgical treatment, varying by treatment scenario.)
- Incremental Cost-Effectiveness Ratio (Study 3)(Time frame: 12 months from diagnosis.)
- Health Literacy (Study 4)(At inclusion before any treatment, at 6 months, and at 12 months from inclusion.)
研究者
Jennie Engstrand
MD, PhD
Karolinska Institutet