|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 24, 2007 | ||||
| Last Updated Date | May 24, 2007 | ||||
| Start Date ICMJE | January 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
overall survival [ Time Frame: 5 years ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
tumor response [ Time Frame: 1-6 months ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm | ||||
| Official Title ICMJE | Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm | ||||
| Brief Summary | Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm. |
||||
| Detailed Description | To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the factors affecting the outcomes. The patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. The primary end point was survival, and the secondary end points were tumor response. |
||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Hepatocellular Carcinoma | ||||
| Intervention ICMJE | Procedure: chemoembolization ,Radiofrequency ablation | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Cheng BQ, Jia CQ, Liu CT, Fan W, Wang QL, Zhang ZL, Yi CH. Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm: a randomized controlled trial. JAMA. 2008 Apr 9;299(14):1669-77. | ||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 291 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Eligibility criteria were:
Exclusion Criteria: Exclusion criteria were:
|
||||
| Gender | Both | ||||
| Ages | 45 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00479050 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2001HCC, 03BS035 | ||||
| Study Sponsor ICMJE | Shandong University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Shandong University | ||||
| Verification Date | May 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||