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

NCT00556803 | Unknown Phase 4 DMC

• 1 other identifier: rfa-003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Liver Cancer

Keywords

hepatocellular carcinoma; liver cancer; radiofrequency ablation; transcatheter arterial chemoembolization; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Overall survivals

  3, and 5-years

Secondary Outcomes (1)

• Recurrence rates

  3, and 5-years

Study Arms (2)

1

EXPERIMENTAL

TACE after RFA within one month as an adjuvant therapy

Procedure: TACE after RFA

2

ACTIVE COMPARATOR

RFA alone

Procedure: radiofrequency ablation

Interventions

radiofrequency ablation PROCEDURE

radiofrequency ablation

Also known as: RFA

2

TACE after RFA PROCEDURE

TACE after RFA within one month

Also known as: TACE-RFA

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (3)

• Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004.

  PMID: 11923602 BACKGROUND

• Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.

  PMID: 16495695 BACKGROUND

• Buscarini L, Buscarini E, Di Stasi M, Vallisa D, Quaretti P, Rocca A. Percutaneous radiofrequency ablation of small hepatocellular carcinoma: long-term results. Eur Radiol. 2001;11(6):914-21. doi: 10.1007/s003300000659.

  PMID: 11419162 BACKGROUND

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, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Shan Chen, M.D, Ph.D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: June 1, 2010
• Last Updated: November 18, 2008

Record last verified: 2008-11

Locations

CN (1)