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Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00874406
Recruitment Status : Unknown
Verified April 2009 by Fudan University.
Recruitment status was:  Recruiting
First Posted : April 2, 2009
Last Update Posted : April 2, 2009
Sponsor:
Information provided by:
Fudan University

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 2, 2009
Last Update Posted Date April 2, 2009
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
progression free survival [ Time Frame: 5 years after operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
overall survival [ Time Frame: 5 years after operation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Official Title  ICMJE Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Brief Summary The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.
Detailed Description We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: tac + folfox4
    tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later: operation within 28 days after operation: folfox4
  • Drug: folfox4
    folfox4 will be done within 28 days after liver resection
Study Arms  ICMJE
  • Experimental: 1
    transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
    Intervention: Drug: tac + folfox4
  • Active Comparator: 2
    Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
    Intervention: Drug: folfox4
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 1, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age <= 75 years
  • resectable liver metastasis
  • remnant liver volume >= 70%
  • without other organ metastasis or peritoneum metastasis
  • without contradiction of cardiac and pulmonary diseases

Exclusion Criteria:

  • age > 75 years
  • unresectable liver metastasis
  • remnant liver volume < 50%
  • with other organ metastasis or peritoneum metastasis
  • with contradiction of cardiac and pulmonary diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00874406
Other Study ID Numbers  ICMJE 2009-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xujianmin, Zhongshan hospital, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: jianmin xu, MD, PHD department of general surgery, zhongshan hospital, fudan university
PRS Account Fudan University
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP