Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma (RFA and TACE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00554905
First received: November 6, 2007
Last updated: February 6, 2009
Last verified: February 2009
  Purpose

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
Hepatocellular Carcinoma
Liver Cancer
Procedure: Radiofrequency ablation
Procedure: TACE
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 3, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence rates [ Time Frame: 3, 5-years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TACE first, then RFA within 2 weeks
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).
Other Name: RFA
Procedure: TACE
TACE first, then RFA within 2 weeks
Other Name: RFA-TACE
Active Comparator: 2
RFA alone
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).
Other Name: RFA

Detailed Description:

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.

  Eligibility

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

Inclusion Criteria:

  • Age 18 - 75 years, who refused surgery
  • A solitary HCC ≤ 7.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
  • Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US
  • No extrahepatic metastasis
  • No imaging evidence of invasion into the major portal/hepatic vein branches
  • No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
  • A platelet count of > 40,000/mm3
  • No previous treatment of HCC except liver resection

Exclusion Criteria:

  • Patient compliance is poor
  • The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted.
  • History of cardiac disease:

    • Congestive heart failure > New York Heart Association (NYHA) class 2
    • Active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted)
    • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
    • Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
  • Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
  • Known history of human immunodeficiency virus (HIV) infection
  • Known central nervous system tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • Distantly extrahepatic metastasis
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
  • Excluded therapies and medications, previous and concomitant:

    • Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.
    • Prior use of systemic investigational agents for HCC
    • Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
  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: NCT00554905

Contacts
Contact: Min-Shan Chen, Doctor 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn

Locations
China, Guangdong
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Min-Shan Chen, Doctor    86-20-87343117 ext 86-20-87343117    Chminsh@mail.sysu.edu.cn   
Principal Investigator: Min-Shan Chen, Doctor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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
  More Information

Publications:
Bruix J, Sherman M. Management of hepatocellular carcinoma. Hepatology 2005; 42(5):1208-1236

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00554905     History of Changes
Other Study ID Numbers: rfa-001
Study First Received: November 6, 2007
Last Updated: February 6, 2009
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
ablation
catheter
Carcinoma, Hepatocellular
therapy
Chemoembolization, Therapeutic
Humans
Liver Neoplasms

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

ClinicalTrials.gov processed this record on July 24, 2014