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Chemotherapy for Resectable Colorectal Liver Metastases

NCT04513457 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 967

Last updated 2021-03-29

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Liver resection and Neoadjuvant chemotherapy

OTHER

Liver resection and Adjuvant chemotherapy

OTHER

Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy

PROCEDURE

Liver resection

Sponsors & Collaborators

  • Marcello Di Martino

    collaborator UNKNOWN

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2020-07-31
Completion
2020-09-30

Countries

  • France
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04513457 on ClinicalTrials.gov