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Sponsored by: |
Sun Yat-sen University |
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Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00554905 |
The purpose of this study is to prospectively evaluate whether combined RFA and TACE (RFA-TACE) result in better survival outcomes than RFA alone in patients with HCC.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma Liver Cancer |
Procedure: Radiofrequency ablation Procedure: RFA after TACE |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma |
Estimated Enrollment: | 180 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
RFA after TACE
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Procedure: RFA after TACE
TACE first, then RFA within 2 weeks
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2: Active Comparator
RFA alone
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Procedure: Radiofrequency ablation
For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, California, USA) and a needle electrode with a 15-gauge insulated cannula with 10 hook-shape expandable electrode tines with a diameter of 3.5cm at expansion (LeVeen; RadioTherapeutics, Mountain View, California, USA).
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Local ablation is a safe and effective therapy for patients who cannot undergo resection, or as a bridge to transplantation. Of the various percutaneous local ablative therapies, radiofrequency ablation (RFA) has attracted the greatest interest because of its effectiveness and safety for small HCC ≤ 5.0cm, with a 3-year survival rate of 62% to 68%, a low treatment morbidity of 0% to 12%, and a low treatment mortality of 0% to 1%. Prospective randomized trials have shown RFA to be better than percutaneous ethanol injection (PEI) in producing a higher rate of complete tumor necrosis with fewer numbers of treatment sessions and better survival.
Unfortunately, the complete tumor necrosis rate for tumors larger than 5cm is less favorable, and the local recurrence rate can be as high as 20% even in small HCC less than 3.5cm. The high local recurrence rate may be due to residual cancer cells not killed by RFA or adjacent microscopic satellite tumor nodules.
Transcatheter Arterial Chemoembolization (TACE) is proved to be an effective and palliative therapy for unresectable HCC. And some studies showed that combined TACE and RFA may produce superior tumor control than RFA alone and reduce local recurrence rate. In a study by Yamakado et al., 64 patients with 92 tumors underwent RFA within two weeks after TACE. The intrahepatic recurrence rates were 15% at 1 year and 43% at 2years, the 1, and 2, year overall survivals were 100% and 93%, respectively. These results appeared favorable, but there has not a prospective randomized controlled study to compare RFA combine with TACE versus RFA alone.
Thus the purpose of our study was to prospectively evaluate whether combined RFA and TACE (RFA-TACE) result in better survival outcomes than RFA alone in patients with HCC.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of cardiac disease:
Excluded therapies and medications, previous and concomitant:
Contact: Min-Shan Chen, Doctor | 86-20-87343117 ext 86-20-87343117 | Chminsh@mail.sysu.edu.cn |
China, Guangdong Province | |
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong Province, China, 510060 | |
Contact: Min-Shan Chen, Doctor 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn | |
Contact: Min-Shan Chen, Doctor 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn | |
Principal Investigator: Min-Shan Chen, Doctor |
Principal Investigator: | Min-Shan Chen, Doctor | Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University |
Study Chair: | Jin-Qing Li, Doctor | Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University |
Responsible Party: | Cancer Center, Sun Yat-sen University ( Cancer Center, Sun Yat-sen University ) |
Study ID Numbers: | rfa-001 |
Study First Received: | November 6, 2007 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00554905 |
Health Authority: | China: Ministry of Health |
ablation, catheter Carcinoma, Hepatocellular/*therapy *Chemoembolization, Therapeutic Humans Liver Neoplasms/*therapy |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |