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Brief Title: 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 ID: NCT04513457
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier Universitaire de Reims, Reims, , France
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Hospital Clínico Universitario de Valencia, Valencia, Comunidad Valenciana, 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
Liverpool University Hospitals NHS Foundation Trust, Liverpool, , United Kingdom