TACE as an Adjuvant Therapy After Radiofrequency Ablation (RFA) for Hepatocellular Carcinoma (TACE-RFA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00556803
First received: November 9, 2007
Last updated: November 17, 2008
Last verified: November 2008
  Purpose

The purpose of this study is to prospectively evaluate whether transcatheter arterial chemoembolization (TACE) will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.


Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
Procedure: radiofrequency ablation
Procedure: TACE after RFA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Resource links provided by NLM:


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

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

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

Estimated Enrollment: 120
Study Start Date: November 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TACE after RFA within one month as an adjuvant therapy
Procedure: TACE after RFA
TACE after RFA within one month
Other Name: TACE-RFA
Active Comparator: 2
RFA alone
Procedure: radiofrequency ablation
radiofrequency ablation
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 ≤ 5.0 cm, 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 5 cm is less favorable, and the local recurrence rate can be as high as 20% even in small HCC less than 3.5 cm. 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) has proven to be an effective and palliative therapy for unresectable HCC. And some prospective randomized controlled trials have shown that adjuvant TACE after curative resection for HCC can improve the overall survivals and decrease the recurrence rates. But there have not been any studies about TACE as an adjuvant therapy after RFA for HCC.

Thus, the purpose of this study is to prospectively evaluate whether TACE as an adjuvant therapy after RFA for HCC will improve the outcomes of RFA.

  Eligibility

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

Inclusion Criteria:

  • Aged 18 - 75 years, and refused surgery
  • A solitary HCC ≤ 7.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0 cm 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 so that TACE cannot 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 and 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
    • 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 to 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556803

Contacts
Contact: Min-Shan Chen, M.D, Ph.D 86-20-87343117 Chminsh@mail.sysu.edu.cn

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

Publications:
Responsible Party: Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00556803     History of Changes
Other Study ID Numbers: rfa-003
Study First Received: November 9, 2007
Last Updated: November 17, 2008
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
hepatocellular carcinoma
liver cancer
radiofrequency ablation
transcatheter arterial chemoembolization
adjuvant therapy

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 April 17, 2014