Chemotherapy for Resectable Colorectal Liver Metastases

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Status: Completed

Conditions: Metastatic Colorectal Cancer; Metastatic Liver Cancer

Treatments: Other: Liver resection and Neoadjuvant chemotherapy; Other: Liver resection and Adjuvant chemotherapy; Procedure: Liver resection; Other: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT04513457

Chemotherapy-liver-metastases

Details and patient eligibility

About

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.

Enrollment: 967 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

967 participants in 4 patient groups

Liver resection and Neoadjuvant chemotherapy

Description:

Liver resection and Neoadjuvant chemotherapy

Treatment:

Other: Liver resection and Neoadjuvant chemotherapy

Liver resection and Adjuvant chemotherapy

Description:

Liver resection and Adjuvant chemotherapy

Treatment:

Other: Liver resection and Adjuvant chemotherapy

Liver resection, Neoadjuvant and Adjuvant chemotherapy

Description:

Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy

Treatment:

Other: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy

Liver resection

Description:

Liver resection

Treatment:

Procedure: Liver resection