Clinical trial NCT01963429: Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC
Official title: A Randomized Phase III Study of the Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation in Patients With Recurrent/Residual Small Hepatocellular Carcinoma (APROH Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Small Hepatocellular Carcinoma
Residual Small Hepatocellular Carcinoma
Keywords: hepatocellular
Proton
RFA
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-10-16
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.

Detailed description: The sample size for this study was based on a non-inferiority design. Primary objective: estimate local progression-free survival (LPFS) rate in two treatments Primary endpoint: 2-year LPFS rate Expected 2-year LPFS rate in the RFA: 85% Accural time and follow up time: 24 months and 24 months, respectively. Precision for 2-year LPFS rate estimation: Allowing a difference of 15% as the non-inferiority margin, with a power of 80% and a type I error level of 5%, evaluable 68 patients are required.

Considering 5% of follow-up loss, we need 72 patients in each arm, so a total of 144 patients will be enrolled.

Eligibility criteria: Inclusion Criteria:

* HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
* HCC patients who had recurrent or residual tumor after other treatments
* without evidence of extrahepatic metastasis
* the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2
* no previous treatment to target tumors by other forms of RT
* liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7)
* Age of ≥18 years
* performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
* WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 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 RT adjacent to target tumors
* poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
* pregnant or breast feeding status
* previous history uncontrolled other malignancies within 2 years

Primary outcomes:
measure: local progression-free survival(LPES)
timeFrame: up to 2 year
Secondary outcomes:
measure: disease-free survival (DFS)
timeFrame: up to 2 years until study closed
Other outcomes:
measure: overall survival (OS)
timeFrame: up to 2 years until study closed
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Joong Won Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim TH, Koh YH, Kim BH, Kim MJ, Lee JH, Park B, Park JW. Proton beam radiotherapy vs. radiofrequency ablation for recurrent hepatocellular carcinoma: A randomized phase III trial. J Hepatol. 2021 Mar;74(3):603-612. doi: 10.1016/j.jhep.2020.09.026. Epub 2020 Oct 5.