Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.

Official Title
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radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Radiofrequency ablation with radiotherapy
* Drug: Radiofrequency ablation alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnoses of hepatocellular carcinoma based on EASL. Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm. Patients must have a performance status of ECOG score < 2. Patients must have adequate liver reservation and adequate hemogram. Pugh-Child's Score < 7. The serum total bilirubin level are < 2 mg/dl. The prothrombin times are < 3 sec above normal control. The platelet are > 75 x 109/L. Patient must have serum creatinine < 1.5 mg/dl Cardiac function with NYHA classification < Grade II HBsAg (+) . Signed informed consent. Exclusion Criteria: HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible. Patients with advanced second primary malignancy are not eligible. Patients with pregnancy or breast-feeding are not eligible. Patients with severe cardiopulmonary diseases are not eligible. Patients with clinically significant psychiatric disorder are not eligible. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible. Patients who had prior antitumor therapy for HCC are not eligible. Anti-HCV positive patients are not eligible.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Radiofrequency Ablation with or without Radiotherapy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency ablation with radiotherapy<br>Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma. | Drug: Radiofrequency ablation with radiotherapy<br>* Radiofrequency ablation with radiotherapy<br>|
| Active Comparator: Radiofrequency ablation alone<br>Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma. | Drug: Radiofrequency ablation alone<br>* Radiofrequency ablation without radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 2-years recurrence rate | Two year recurrence rate between the two groups will be compared. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 2-years recurrence-free survival | Two year recurrence-free survival between the two groups will be compared. | 2 year | 
| the 2-years overall survival. | Two year overall survival between the two groups will be compared. | 2 year |