Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer - Full Text View

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00874406

Purpose

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	Intervention	Phase
Colorectal Cancer	Drug: tac + folfox4 Drug: folfox4	Phase IV

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

Further study details as provided by Fudan University:

Primary Outcome Measures:

progression free survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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

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.

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874406

Contacts

Contact: jianmin xu, MD, PHD

008613501984869

xujmin@yahoo.com.cn

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

Principal Investigator:

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:	2009-04
Study First Received:	April 1, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00874406 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Fudan University:

colorectal cancer
liver metastasis
neoadjuvant chemotherapy

Study placed in the following topic categories:

Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Neoplasm Metastasis

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on May 07, 2009