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Surgery Outcome Treated by Neo-adjuvant Chemotherapy FOLFOXIRI Regimen in Colorectal Cancer With Liver-limited Synchronous Metastases
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Cho Ray hospital- 201 B Nguyen Chi Thanh, District 5
Ho Chi Minh City, Vietnam
Start Date
February 18, 2022
Primary Completion Date
December 20, 2024
Completion Date
January 23, 2025
Last Updated
May 11, 2022
89
ESTIMATED participants
Neo-adjuvant Chemotherapy FOLFOXIRI Regimen
DRUG
synchronous resection surgery
PROCEDURE
Lead Sponsor
Cho Ray Hospital
Collaborators
NCT04668872
NCT05775146
Data Source & Attribution
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