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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Liver Tumor

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Jianmin Xu, M.D.,Ph.D.; Phone Number: 86-13501984869; Email: xujmin@yahoo.com.cn
      • Principal Investigator: Jianmin Xu, M.D.,Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

From Zhongshan hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
arm A; patients received chemotherapy alone
arm B; patients received target therapy combined with chemotherapy

Collaborators and Investigators

• Sponsor: Xu jianmin
• Collaborators: Fudan University
• Investigators: Study Chair: Xu Jianmin, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: August 30, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (ESTIMATE): September 3, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 3, 2012
• Last Update Submitted That Met QC Criteria: August 30, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: chemotherapy; bevacizumab; cetuximab; colorectal liver metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: ZSTCC; Xjianmin (REGISTRY: Xjianmin)