Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE - Full Text View

Sponsors and Collaborators:	Southwest Hospital, China Chongqing Science&Technology Commission
Information provided by:	Southwest Hospital, China
ClinicalTrials.gov Identifier:	NCT00730860

Purpose

A prospective randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.

Condition	Intervention
Cancer of Liver	Procedure: radiofrequency ablation associated with TACE Procedure: radiofrequency ablation only

MedlinePlus related topics: Cancer Liver 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:	Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization——a Prospective Randomized Clinical Trial

Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:

disease free survival [ Time Frame: 1,2,3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total survival [ Time Frame: 1,2,3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization	Procedure: radiofrequency ablation associated with TACE treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
2: Active Comparator treatment of hepatocellular carcinoma by radiofrequency ablation only	Procedure: radiofrequency ablation only treatment of hepatocellular carcinoma by radiofrequency ablation only

Detailed Description:

A prospective randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with hepatocellular,confirmed by pathological examination
patients with a live function test showed Child A or B
Indocyanine green test showed less than 30％ after 15min,and the patients showed a tolerance of RFA and TACE
Tumor stage is early period(according to Milan Standard),that is,the diameter of single node should be less than 5cm；the node of tumor should be less than 3 and the diameter less than 3cm.
without metastasis in lymphnode or other organs
written consent inform assigned

Exclusion Criteria:

preoperative examination showed malignant thrombosis in the first class branch of portal vein or hepatic vein or vena cava
metastatic cancer of liver
patients with a poor tolerance of RFA and TACE
patients received other therapies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730860

Contacts

Contact: Feng Xiaobin, M.D

+86-23-68765297

fengxiaobin200708@yahoo.com.cn

Locations

China
Institute of hepatobiliary surgery	Recruiting
Chongqing, China, 400038
Contact: Ma Kuansheng, Ph.D 86-23-68765297 xiaobinf@medmail.com.cn
Principal Investigator: Feng Xiaobin, M.D

Sponsors and Collaborators

Southwest Hospital, China

Chongqing Science&Technology Commission

Investigators

Study Director:

Ma Kuansheng, Ph.D

Institute of Hepatobiliary surgery , Southwest hospital

More Information

the official website of the Institute of hepatobiliary surgery This link exits the ClinicalTrials.gov site

Responsible Party:	Southwest Hospital ( feng xiaobin )
Study ID Numbers:	SWHB002
Study First Received:	August 6, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00730860
Health Authority:	China: Ethics Committee

Keywords provided by Southwest Hospital, China:

radiofrequency ablation
Cancer of Liver
postoperative
transhepatic arterial chemoembolization
prospective

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009