Chemotherapy for Resectable Colorectal Liver Metastases

Metastatic Colorectal Cancer Clinical Trial

Official title:

Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513457
• Other study ID #: Chemotherapy-liver-metastases
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2021
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 967
• Est. completion date: September 30, 2020
• Est. primary completion date: July 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Colorectal Cancer
• Metastatic Liver Cancer
• Neoplasm Metastasis

Intervention

Other:
• Liver resection and Neoadjuvant chemotherapy

• Liver resection and Adjuvant chemotherapy

• Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy

Procedure:
• Liver resection

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Reims	Reims
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Dr. Josep Trueta	Girona
Spain	Hospital Universitario de Jaén	Jaén
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Clínico Universitario de Valencia	Valencia	Comunidad Valenciana
United Kingdom	Liverpool University Hospitals NHS Foundation Trust	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Marcello Di Martino

Countries where clinical trial is conducted

France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival based on perioperative treatment	Overall survival based on perioperative treatment	5 years of follow-up
Primary	Cancer survival based on perioperative treatment	Cancer survival based on perioperative treatment	5 years of follow-up
Primary	Disease-free survival based on perioperative treatment	Disease-free survival based on perioperative treatment	5 years of follow-up
Primary	Peri-operative morbidity	Peri-operative morbidity	5 years of follow-up
Primary	Peri-operative mortality	Peri-operative mortality	5 years of follow-up
Secondary	Overall survival, cancer survival and disease-free survival related with biological markers	Overall survival, cancer survival and disease-free survival related with biological markers	5 years of follow-up
Secondary	Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.	Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.	5 years of follow-up
Secondary	Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.	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