Clinical trial · Observational
Chemotherapy for Resectable Colorectal Liver Metastases
Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx. There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM. This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver resection | Procedure | — | UNRESOLVED |
| Liver resection and Adjuvant chemotherapy | Other | — | UNRESOLVED |
| Liver resection and Neoadjuvant chemotherapy | Other | — | UNRESOLVED |
| Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Liver resection and Neoadjuvant chemotherapy
- description
- Liver resection and Neoadjuvant chemotherapy
- interventionNames
- Other: Liver resection and Neoadjuvant chemotherapy
- label
- Liver resection and Adjuvant chemotherapy
- description
- Liver resection and Adjuvant chemotherapy
- interventionNames
- Other: Liver resection and Adjuvant chemotherapy
- label
- Liver resection, Neoadjuvant and Adjuvant chemotherapy
- description
- Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
- interventionNames
- Other: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma. * Minimum follow-up of five years. Exclusion Criteria: * Patients with extrahepatic disease
References
Publications (0)
Data not yet available