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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

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: tac + folfox4 Drug: folfox4 Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009


Arm Intervention/treatment
Experimental: 1
transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
Drug: tac + folfox4
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later: operation within 28 days after operation: folfox4

Active Comparator: 2
Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
Drug: folfox4
folfox4 will be done within 28 days after liver resection




Primary Outcome Measures :
  1. progression free survival [ Time Frame: 5 years after operation ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years after operation ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00874406


Contacts
Contact: jianmin xu, MD, PHD 008613501984869 xujmin@yahoo.com.cn

Locations
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: jianmin xu, MD, PHD    008613501984869    xujmin@yahoo.com.cn   
Principal Investigator: jianmin xu, MD, PHD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: jianmin xu, MD, PHD department of general surgery, zhongshan hospital, fudan university

Responsible Party: Xujianmin, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00874406     History of Changes
Other Study ID Numbers: 2009-04
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: April 2, 2009
Last Verified: April 2009

Keywords provided by Fudan University:
colorectal cancer
liver metastasis
neoadjuvant chemotherapy

Additional relevant MeSH terms:
Colorectal 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
Neoplastic Processes
Pathologic Processes
Fluorouracil
Oxaliplatin
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances