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Spots Global Cancer Trial Database for Chemotherapy for Resectable Colorectal Liver Metastases

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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