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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Xu jianmin, Fudan University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01677728
First Posted: September 3, 2012
Last Update Posted: September 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fudan University
Information provided by (Responsible Party):
Xu jianmin, Fudan University
  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

Further study details as provided by Xu jianmin, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Shanghai Zhongshan Hospital
  More Information

Responsible Party: Xu jianmin, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01677728     History of Changes
Other Study ID Numbers: ZSTCC
Xjianmin ( Registry Identifier: Xjianmin )
First Submitted: August 30, 2012
First Posted: September 3, 2012
Last Update Posted: September 3, 2012
Last Verified: August 2012

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

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