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Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer

Liver Metastasis Colon Cancer Clinical Trial

Official title:
Surgery Outcome Treated by Neo-adjuvant Chemotherapy FOLFOXIRI Regimen in Colorectal Cancer With Liver-limited Synchronous Metastases

Clinical Trial Summary

This single arm study aims to evaluate the rate of conversion therapy in patients with unresectable liver-limited metastatic colorectal cancer (mCRC) using FOLFOXIRI neoadjuvant regimen and to assess the other outcome including the response rate, the survival rate and the safety profile.

Clinical Trial Description

Patients with liver-only metastases colorectal cancer could potentially be cured following surgical resection of metastases. Recent evidence suggest that a triplet chemotherapy regimen, FOLFOXIRI has been associated with higher R0 resection. Eighty-nine eligible patients will be recruited at Cho Ray hospital in Vietnam. Patients will receive neoadjuvant FOLFOXIRI regimen every two weeks for up to 12 cycles and will undergo periodic imaging studies. The resectability of liver metastases will be assessed by a multidisciplinary team comprised of digestive surgeons, hepato-biliary surgeons, radiologists, and oncologists. This study will be helpful to establish a standard chemotherapy regimen for patients with liver-limited metastatic colorectal cancer. Moreover, this study will assess the surgical outcome, the response rate, the survival rate, the safety of triple drug chemotherapy and the association between conversion operable disease and various survival rate and patient's characteristics. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05362825
Study type Observational
Source Cho Ray Hospital
Contact Hao Dinh Thy Vuong, MD
Phone +84913122867
Email drthyhao@gmail.com
Status Recruiting
Phase
Start date February 18, 2022
Completion date January 23, 2025
View Details
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