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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00868569
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention Phase
Liver Metastasis
Colorectal Cancer
 Procedure: TACE + folfox 4
Procedure: TAC + folfox4
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • resection rate of liver metastasis progression-free survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Xujianmin, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00868569     History of Changes
Other Study ID Numbers: 2009-03
Study First Received: March 24, 2009
Last Updated: March 24, 2009
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013