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

This study is currently recruiting participants.
Verified August 2012 by Fudan University
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Xu jianmin, Fudan University
ClinicalTrials.gov Identifier:
NCT01677728
First received: August 30, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition
Colorectal Cancer
Liver Tumor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized, Controlled Trial of Target Therapy Plus Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Estimated Enrollment: 60
Study Start Date: January 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
arm A
patients received chemotherapy alone
arm B
patients received target therapy combined with chemotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

From Zhongshan hospital

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677728

Contacts
Contact: Xu Jianmin, MD +86-13501984869 xujmin@yahoo.com.cn

Locations
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jianmin Xu, M.D.,Ph.D.     86-13501984869     xujmin@yahoo.com.cn    
Principal Investigator: Jianmin Xu, M.D.,Ph.D.            
Sponsors and Collaborators
Xu jianmin
Fudan University
Investigators
Study Chair: Xu Jianmin, MD Zhongshan hospital
  More Information

No publications provided

Responsible Party: Xu jianmin, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01677728     History of Changes
Other Study ID Numbers: ZSTCC, Xjianmin
Study First Received: August 30, 2012
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Fudan University:
colorectal liver metastases
chemotherapy
cetuximab
bevacizumab

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013