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

Colorectal Cancer Clinical Trial

Official title:

A Randomized, Controlled Trial of Target Therapy Plus Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01677728
• Other study ID #: ZSTCC
• Secondary ID: Xjianmin
• Status: Recruiting
• Phase: N/A
• First received: August 30, 2012
• Last updated: August 30, 2012
• Start date: January 2007
• Est. completion date: December 2014

Study information

• Verified date: August 2012
• Source: Fudan University
• Contact: Xu Jianmin, MD
• Phone: +86-13501984869
• Email: xujmin[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Liver Tumor

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Xu jianmin	Fudan University

Country where clinical trial is conducted

China,