Effect of Target Therapy on Patients Undergoing Synchronic Hepatectomy for Colorectal Liver Metastases

• Conditions: Colorectal Cancer; Liver Tumor

• Registration Number: NCT01677728
• Lead Sponsor: Xu jianmin

Brief Summary

The aim of this study is to explore whether target therapy in combination with chemotherapy as treatment could improve survival or tumor response in patients undergoing Synchronic Hepatectomy for Colorectal Liver Metastases.

Detailed Description

In patients with colorectal cancer (CRC), the liver is the most common site of hematogenous metastases. Approximately half of patients develop hepatic metastases during the course of the disease, and hepatic metastases are responsible for death in at least two thirds of CRC patients.

Over the past decade, due to the introduction of irinotecan-based or oxaliplatin-based combination chemotherapy, the median survival among patients with colorectal liver metastases (CLM) has increased from 6 \~8 months to more than 20 months5.In recent years, target therapy has rapidly gained attention for the treatment of CLM and is under active investigation.

Although numerous publications have reported the efficacy of target therapy in combination treatment for CLM patients, most of these studies focused solely on those patients without undergoing resection of liver metastases. In contrast, little work has concentrated on exploring the effection of target therapy for CLM patients undergoing Synchronic Hepatectomy.

Study Timeline

• Study Start: 2007-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-30
• Last Update Submitted: 2012-08-30
• Study First Posted: 2012-09-03
• Last Update Posted: 2012-09-03
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age between 18 - 75 years old
• Performance status (ECOG) 0~1
• colorectal adenocarcinoma pathologically
• without any chemotherapy or radiotherapy
• liver metastases undergoing radical resection
• colorectal cancer undergoing radical resection
• no other metastases
• suitable for chemotherapy
• agreed by patients

Exclusion Criteria

• age below 18 years old or greater than 75 years old
• haven't pathological diagnosis of colorectal adenocarcinoma with liver metastase
• with any chemotherapy or radiotherapy
• with other metastasis
• unresectable colorectal cancer or liver metastases
• unsuitable for chemotherapy or target therapy
• not agreed by patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China