Chemotherapy for Resectable Colorectal Liver Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

967 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer Metastatic Liver Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Liver resection and Neoadjuvant chemotherapy

Intervention Type OTHER

Liver resection and Adjuvant chemotherapy

Intervention Type OTHER

Liver resection, Neoadjuvant and Adjuvant chemotherapy

Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy

Intervention Type OTHER

Liver resection

Intervention Type PROCEDURE

Interventions

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Liver resection and Neoadjuvant chemotherapy

Intervention Type OTHER

Liver resection and Adjuvant chemotherapy

Intervention Type OTHER

Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy

Intervention Type OTHER

Liver resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma.
* Minimum follow-up of five years.