Influence of Neoadjuvant Therapy on the Resectability of Hepatic Metastases From Colorectal Cancers

Colorectal Cancer Clinical Trial

Official title: Influence of Neoadjuvant Therapy on the Resectability of Hepatic Metastases From Colorectal Cancers

Status Recruiting

Clinical Trial Summary

More and more colorectal surgeons believe that surgical resections of hepatic metastases from colorectal cancer is the only chance for cure of patients. The five-year survival for patients with hepatic metastasis from colorectal cancer after surgical resection is approximately 30 %. However, most hepatic metastases from colorectal cancer were inoperable. With the progress of chemotherapy, for example, the combination of the 5-Fu, leucovorin, and oxaliplatin, some surgeons advocated that approximately 20% of inoperable liver metastases will be converted to operable case, thus providing the long-term survival for patients. In this study, we made a phase Ⅱ clinical trial regarding the use of the Folfox-4 regimens in the neo-adjuvant treatment of inoperable hepatic metastases. Our aims is to evaluate the tumor response rate for this regimen, the rate of resectability of liver metastases, progression free survival and overall survival of patients. In addition, the difference between the reports from Western and Oriental countries will be analyzed. We believe this study will provide new perspectives regarding the most beneficial treatment modalities for the patients with hepatic metastases from colorectal cancer.

Clinical Trial Description

More and more colorectal surgeons believe that surgical resections of hepatic metastases from colorectal cancer is the only chance for cure of patients. The five-year survival for patients with hepatic metastasis from colorectal cancer after surgical resection is approximately 30 %. However, most hepatic metastases from colorectal cancer were inoperable. With the progress of chemotherapy, for example, the combination of the 5-Fu, leucovorin, and oxaliplatin, some surgeons advocated that approximately 20% of inoperable liver metastases will be converted to operable case, thus providing the long-term survival for patients. In this study, we made a phase Ⅱ clinical trial regarding the use of the Folfox-4 regimens in the neo-adjuvant treatment of inoperable hepatic metastases. Our aims is to evaluate the tumor response rate for this regimen, the rate of resectability of liver metastases, progression free survival and overall survival of patients. In addition, the difference between the reports from Western and Oriental countries will be analyzed. We believe this study will provide new perspectives regarding the most beneficial treatment modalities for the patients with hepatic metastases from colorectal cancer. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00172159
• Study type: Interventional
• Source: National Taiwan University Hospital
• Contact: Jin-Tung Liang, M.D., Ph.
• Phone: 886-2-23562068
• Email: jintung@ha.mc.ntu.edu.tw
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2000
• Completion date: June 2005