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Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00868569
Recruitment Status : Unknown
Verified March 2009 by Fudan University.
Recruitment status was:  Recruiting
First Posted : March 25, 2009
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
Fudan University

Brief Summary:
The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

Condition or disease Intervention/treatment Phase
Liver Metastasis Colorectal Cancer Procedure: TACE + folfox 4 Procedure: TAC + folfox4 Phase 4

Detailed Description:
We administered three cycles FOLFOX4 plus TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall survival as evaluated by intent-to-treat analysis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TAC vs TACE Plus folfox4 as the Treatment of Unresectalbe Liver Metastasis of Colorectal Cancer With Resection of the Primary Tumor: a Prospective, Randomized, Control Trial
Study Start Date : January 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010


Arm Intervention/treatment
Experimental: 1
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again.
Procedure: TACE + folfox 4

tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml

folfox4


Active Comparator: 2
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy (TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.
Procedure: TAC + folfox4

tac: oxaliplatin 100mg + fudr 1g + mmc 10mg

folfox4





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

Secondary Outcome Measures :
  1. resection rate of liver metastasis progression-free 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 with histologically proven adenocarcinoma of the colon or rectum
  • no severe major organ dysfunction
  • WHO performance status of 0 or 1
  • no prior cancer therapy
  • with measurable unresectableliver metastasis
  • without other metastasis

Exclusion Criteria:

  • age >= 75
  • severe major organ dysfunction
  • WHO performance status of >1
  • prior cancer therapy
  • with other metastasis

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): NCT00868569


Contacts
Contact: jianmin xu, MD, PHD 008613501984869 xujmin@yahoo.com.cn
Contact: yunshi zhong, MD 008613564623481 zhongamy2002@126.com

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
Study Director: jianmin xu, MD, PHD department of general surgery, zhongshan hospital, fudan university

Responsible Party: Xujianmin, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00868569     History of Changes
Other Study ID Numbers: 2009-03
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Fudan University:
liver metastasis
colorectal cancer
oxaliplatine
transartery chemotherapy
embolision
Unresectable Liver Metastasis of Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
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
Oxaliplatin
Fluorouracil
Leucovorin
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex