RT-RFA: Radiotherapy as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00557024

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Liver Cancer	Procedure: RFA Procedure: radiotherapy after RFA	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Radiotherapy as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Study Start Date :

Nov 1, 2007

Anticipated Primary Completion Date :

Nov 1, 2009

Anticipated Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 radiotherapy after RFA	Procedure: radiotherapy after RFA radiotherapy after RFA Other Names: RT-RFA
Active Comparator: 2 RFA alone	Procedure: RFA radiofrequency ablation

Arm

Intervention/Treatment

Experimental: 1

radiotherapy after RFA

Procedure: radiotherapy after RFA

radiotherapy after RFA

Other Names:

RT-RFA

Active Comparator: 2

RFA alone

Procedure: RFA

radiofrequency ablation

Outcome Measures

Primary Outcome Measures

Overall survivals [3, abd 5-years]

Secondary Outcome Measures

Recurrence rates [3-, and 5-years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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