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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04513457
Enrollment
967
Registered
2020-08-14
Start date
2010-01-01
Completion date
2020-09-30
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer, Metastatic Liver Cancer

Keywords

Colorectal liver metastases, Liver resection, Hepatectomy

Brief summary

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.

Interventions

OTHERLiver resection and Neoadjuvant chemotherapy
OTHERLiver resection and Adjuvant chemotherapy
OTHERLiver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
PROCEDURELiver resection

Sponsors

Marcello Di Martino
CollaboratorUNKNOWN
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Peri-operative mortality5 years of follow-upPeri-operative mortality
Cancer survival based on perioperative treatment5 years of follow-upCancer survival based on perioperative treatment
Disease-free survival based on perioperative treatment5 years of follow-upDisease-free survival based on perioperative treatment
Peri-operative morbidity5 years of follow-upPeri-operative morbidity
Overall survival based on perioperative treatment5 years of follow-upOverall survival based on perioperative treatment

Secondary

MeasureTime frameDescription
Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.5 years of follow-upOverall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.
Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.5 years of follow-upOverall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.
Overall survival, cancer survival and disease-free survival related with biological markers5 years of follow-upOverall survival, cancer survival and disease-free survival related with biological markers

Countries

France, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026