Clinical trial NCT04513457: Chemotherapy for Resectable Colorectal Liver Metastases
Official title: Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Metastatic Liver Cancer
Keywords: Colorectal liver metastases
Liver resection
Hepatectomy
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
Collaborators: name: Marcello Di Martino
First posted: 2020-08-14
Enrollment: 967
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing liver resection for colorectal metastases between January 1, 2010 and December 31, 2014, inclusive

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival based on perioperative treatment
timeFrame: 5 years of follow-up
measure: Cancer survival based on perioperative treatment
timeFrame: 5 years of follow-up
measure: Disease-free survival based on perioperative treatment
timeFrame: 5 years of follow-up
measure: Peri-operative morbidity
timeFrame: 5 years of follow-up
measure: Peri-operative mortality
timeFrame: 5 years of follow-up
Secondary outcomes:
measure: Overall survival, cancer survival and disease-free survival related with biological markers
timeFrame: 5 years of follow-up
measure: Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.
timeFrame: 5 years of follow-up
measure: Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.
timeFrame: 5 years of follow-up
Other outcomes:
Locations:
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
state: Comunidad Valenciana
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Girona
country: Spain
facility: Hospital Dr. Josep Trueta
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
Study officials:
References: