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

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00868569

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 IV

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Chlorotrianisene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental 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
2: Active Comparator 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
Zhongshan Hospital, Fudan University	Recruiting
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:	Zhongshan hospital, Fudan University ( Xujianmin )
Study ID Numbers:	2009-03
Study First Received:	March 24, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00868569 History of Changes
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

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Liver Neoplasms
Oxaliplatin
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Iodine
Colorectal Neoplasms

Additional relevant MeSH terms:

Liver Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Liver Neoplasms

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009