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
1 other identifier
observational
967
3 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedFirst Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedMarch 29, 2021
March 1, 2021
10.6 years
August 11, 2020
March 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Overall survival based on perioperative treatment
Overall survival based on perioperative treatment
5 years of follow-up
Cancer survival based on perioperative treatment
Cancer survival based on perioperative treatment
5 years of follow-up
Disease-free survival based on perioperative treatment
Disease-free survival based on perioperative treatment
5 years of follow-up
Peri-operative morbidity
Peri-operative morbidity
5 years of follow-up
Peri-operative mortality
Peri-operative mortality
5 years of follow-up
Secondary Outcomes (3)
Overall survival, cancer survival and disease-free survival related with biological markers
5 years of follow-up
Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.
5 years of follow-up
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-up
Study Arms (4)
Liver resection and Neoadjuvant chemotherapy
Liver resection and Neoadjuvant chemotherapy
Liver resection and Adjuvant chemotherapy
Liver resection and Adjuvant chemotherapy
Liver resection, Neoadjuvant and Adjuvant chemotherapy
Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
Liver resection
Liver resection
Interventions
Eligibility Criteria
All patients undergoing liver resection for colorectal metastases between January 1, 2010 and December 31, 2014, inclusive
You may qualify if:
- Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma.
- Minimum follow-up of five years.
You may not qualify if:
- Patients with extrahepatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Centre Hospitalier Universitaire de Reims
Reims, France
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Dr. Josep Trueta
Girona, Spain
Hospital Universitario de Jaén
Jaén, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 14, 2020
Study Start
January 1, 2010
Primary Completion
July 31, 2020
Study Completion
September 30, 2020
Last Updated
March 29, 2021
Record last verified: 2021-03