Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma

NCT00554905 | Unknown Phase 4 DMC

• 1 other identifier: rfa-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Liver Cancer

Keywords

ablation; catheter; Carcinoma, Hepatocellular; therapy; Chemoembolization, Therapeutic; Humans; Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  3, 5 years

Secondary Outcomes (1)

• Recurrence rates

  3, 5-years

Study Arms (2)

1

EXPERIMENTAL

TACE first, then RFA within 2 weeks

Procedure: Radiofrequency ablation; Procedure: TACE

2

ACTIVE COMPARATOR

RFA alone

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

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).

Also known as: RFA

1; 2

TACE PROCEDURE

TACE first, then RFA within 2 weeks

Also known as: RFA-TACE

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

• Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.

  PMID: 16250051 BACKGROUND

• Peng ZW, Zhang YJ, Chen MS, Xu L, Liang HH, Lin XJ, Guo RP, Zhang YQ, Lau WY. Radiofrequency ablation with or without transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma: a prospective randomized trial. J Clin Oncol. 2013 Feb 1;31(4):426-32. doi: 10.1200/JCO.2012.42.9936. Epub 2012 Dec 26.

  PMID: 23269991 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Min-Shan Chen, Doctor

  Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Jin-Qing Li, Doctor

  Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Min-Shan Chen, Doctor

CONTACT

86-20-87343117; Chminsh@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: October 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 10, 2009

Record last verified: 2009-02

Locations

CN (1)