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| Descriptive Information Fields | |||||
| Brief Title † | Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm | ||||
| Official Title † | 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. |
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| 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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | overall survival [ Time Frame: 5 years ] | ||||
| Secondary Outcome Measure † | tumor response [ Time Frame: 1-6 months ] | ||||
| Condition † | Hepatocellular Carcinoma | ||||
| Intervention † | Procedure: chemoembolization ,Radiofrequency ablation | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 291 | ||||
| Start Date † | January 2001 | ||||
| Completion Date | December 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria: Eligibility criteria were:
Exclusion Criteria: Exclusion criteria were:
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| Gender | Both | ||||
| Ages | 45 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00479050 | ||||
| Organization ID | 2001HCC | ||||
| Secondary IDs †† | 03BS035 | ||||
| Study Sponsor † | Shandong University | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Shandong University | ||||
| Verification Date | May 2007 | ||||
| First Received Date † | May 24, 2007 | ||||
| Last Updated Date | May 24, 2007 | ||||