Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Fudan University.
Recruitment status was:  Recruiting
Information provided by:
Fudan University Identifier:
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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
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:

Further study details as provided by Fudan University:

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

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

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


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


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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00868569

Contact: jianmin xu, MD, PHD 008613501984869
Contact: yunshi zhong, MD 008613564623481

China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: jianmin xu, MD, PHD    008613501984869   
Principal Investigator: jianmin xu, MD, PHD         
Sponsors and Collaborators
Fudan University
Study Director: jianmin xu, MD, PHD department of general surgery, zhongshan hospital, fudan university
  More Information

Responsible Party: Xujianmin, Zhongshan hospital, Fudan University Identifier: NCT00868569     History of Changes
Other Study ID Numbers: 2009-03
Study First Received: March 24, 2009
Last Updated: March 24, 2009

Keywords provided by Fudan University:
liver metastasis
colorectal cancer
transartery chemotherapy
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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex processed this record on May 25, 2017