- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04513457
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
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Reims, France
- Centre Hospitalier Universitaire de Reims
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Badajoz, Spain
- Hospital Universitario de Badajoz
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Girona, Spain
- Hospital Dr. Josep Trueta
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Jaén, Spain
- Hospital Universitario de Jaen
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Madrid, Spain, 28006
- Hospital Universitario de La Princesa
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Málaga, Spain
- Hospital Universitario Virgen de la Victoria
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Cantabria
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Santander, Cantabria, Spain
- Hospital Universitario Marques de Valdecilla
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spain
- Hospital Clinico Universitario de Valencia
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Liverpool, United Kingdom
- Liverpool University Hospitals NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Liver resection and Neoadjuvant chemotherapy
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Liver resection and Adjuvant chemotherapy
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Liver resection, Neoadjuvant and Adjuvant chemotherapy
Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
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Liver resection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival based on perioperative treatment
Time Frame: 5 years of follow-up
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Overall survival based on perioperative treatment
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5 years of follow-up
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Cancer survival based on perioperative treatment
Time Frame: 5 years of follow-up
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Cancer survival based on perioperative treatment
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5 years of follow-up
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Disease-free survival based on perioperative treatment
Time Frame: 5 years of follow-up
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Disease-free survival based on perioperative treatment
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5 years of follow-up
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Peri-operative morbidity
Time Frame: 5 years of follow-up
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Peri-operative morbidity
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5 years of follow-up
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Peri-operative mortality
Time Frame: 5 years of follow-up
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Peri-operative mortality
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5 years of follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival, cancer survival and disease-free survival related with biological markers
Time Frame: 5 years of follow-up
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Overall survival, cancer survival and disease-free survival related with biological markers
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5 years of follow-up
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Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.
Time Frame: 5 years of follow-up
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Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.
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5 years of follow-up
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Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.
Time Frame: 5 years of follow-up
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Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.
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5 years of follow-up
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chemotherapy-liver-metastases
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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