NCT01963429.

Trial name or title	Comparison between radiofrequency ablation and hypofractionated proton beam radiation for recurrent/residual hepatocellular carcinoma
Methods	Phase III trial
Participants	People with recurrent/residual hepatocellular carcinoma
Interventions	Experimental: Arm A (radiofrequency ablation) Experimental: Arm B (proton beam radiotherapy)
Outcomes	Primary outcome measures: Local progression‐free survival Secondary outcome measures: Disease‐free survival Other outcome measures: Overall survival
Starting date	October 2013
Contact information	Joong Won Park, PhD; jwpark1@ncc.re.kr
Notes	Estimated enrolment: 144 Inclusion criteria: hepatocellular carcinoma diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum alpha‐fetoprotein level greater than 200 IU/mL and a radiologically compatible feature with hepatocellular carcinoma in 1 or more computed tomography (CT)/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum alpha‐fetoprotein level less than 200 IU/mL, and a radiologically compatible feature with hepatocellular carcinoma in 2 or more computed tomography (CT)/MRI/angiograms, or (iii) histological confirmation. hepatocellular carcinoma patients who had recurrent or residual tumour after other treatments. No evidence of extrahepatic metastasis. The largest diameter of tumour should be less than 3 cm, and the number of tumours ≤ 2. No previous treatment to target tumours by other forms of radiotherapy. Liver function of Child‐Pugh class A or B7 (Child‐Pugh score of ≤ 7). Age ≥ 18 years. Performance status of 0 to 2 on the ECOG score. White blood cell count ≥ 2000/mm3; haemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; aspartate aminotransferase and alanine aminotransferase < 5.0× upper limit of normal; no ascites). No serious comorbidities other than liver cirrhosis. Written informed consent. Exclusion criteria: Evidence of extrahepatic metastasis. Age < 18 years. Liver function of Child‐Pugh class B8‐9 and C (Child‐Pugh score of > 7) or uncontrolled cases of active chronic hepatitis B. Previous history of other forms of radiotherapy adjacent to target tumours. Poor performance status of 3 to 4 on the ECOG score. Pregnant or breastfeeding status. Previous history of uncontrolled other malignancies within 2 years.