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Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Southwest Hospital, China.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Agency for Science, Technology and Research
Information provided by (Responsible Party):
feng xiaobin, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT00730860
First received: August 6, 2008
Last updated: November 23, 2012
Last verified: November 2012
  Purpose

A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization——a Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: December 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RFA+TACE
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
Other Name: Group A
Active Comparator: RFA only
treatment of hepatocellular carcinoma by radiofrequency ablation only
Procedure: radiofrequency ablation only
treatment of hepatocellular carcinoma by radiofrequency ablation only
Other Name: Group B

Detailed Description:

A 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
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 ClinicalTrials.gov identifier: NCT00730860

Contacts
Contact: Feng Xiaobin, M.D +86-23-68765297 fengxiaobin200708@yahoo.com.cn

Locations
China, Chongqing
Institute of hepatobiliary surgery Recruiting
Chongqing, 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
Agency for Science, Technology and Research
Investigators
Study Director: Ma Kuansheng, Ph.D Institute of hepatobiliary surgery,Southwest Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: feng xiaobin, Dr Xiaobin Feng, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT00730860     History of Changes
Other Study ID Numbers: SWHB002
Study First Received: August 6, 2008
Last Updated: November 23, 2012
Health Authority: China: Ethics Committee

Keywords provided by Southwest Hospital, China:
radiofrequency ablation
Cancer of Liver
postoperative
transhepatic arterial chemoembolization
prospective

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014