Radiotherapy as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Sun Yat-sen University1 site in 1 country80 target enrollmentNovember 2007

ConditionsHepatocellular Carcinoma Liver Cancer

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 80
Locations: 1
Primary Endpoint: Overall survivals
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the investigators study is to prospectively evaluate whether radiotherapy as an adjuvant therapy after RFA will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

July 2010

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Eligibility 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