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

Study Type

Observational

Enrollment (Actual)

967

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Reims, France
        • Centre Hospitalier Universitaire de Reims
      • Badajoz, Spain
        • Hospital Universitario de Badajoz
      • Girona, Spain
        • Hospital Dr. Josep Trueta
      • Jaén, Spain
        • Hospital Universitario de Jaen
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
    • Cantabria
      • Santander, Cantabria, Spain
        • Hospital Universitario Marques de Valdecilla
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Hospital Clinico Universitario de Valencia
      • Liverpool, United Kingdom
        • Liverpool University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing liver resection for colorectal metastases between January 1, 2010 and December 31, 2014, inclusive

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liver resection and Neoadjuvant chemotherapy
Liver resection and Adjuvant chemotherapy
Liver resection, Neoadjuvant and Adjuvant chemotherapy
Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy
Liver resection

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
Overall survival based on perioperative treatment
5 years of follow-up
Cancer survival based on perioperative treatment
Time Frame: 5 years of follow-up
Cancer survival based on perioperative treatment
5 years of follow-up
Disease-free survival based on perioperative treatment
Time Frame: 5 years of follow-up
Disease-free survival based on perioperative treatment
5 years of follow-up
Peri-operative morbidity
Time Frame: 5 years of follow-up
Peri-operative morbidity
5 years of follow-up
Peri-operative mortality
Time Frame: 5 years of follow-up
Peri-operative mortality
5 years of follow-up

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
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.
Time Frame: 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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Chemotherapy-liver-metastases

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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