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Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC

Primary Purpose

Recurrent Small Hepatocellular Carcinoma, Residual Small Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
radiofrequency ablation
Proton beam therapy
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Small Hepatocellular Carcinoma focused on measuring hepatocellular, Proton, RFA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center, Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A(radiofrequency ablation )

B(Proton)

Arm Description

radiofrequency ablation

hypofractionated proton beam therapy

Outcomes

Primary Outcome Measures

local progression-free survival(LPES)
To evaluate the local progression-free survival for 2 years

Secondary Outcome Measures

disease-free survival (DFS)
Disease-free survival was defined as the interval from the date of randomization to date of detection study closed

Full Information

First Posted
October 13, 2013
Last Updated
October 4, 2020
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01963429
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2013 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Small Hepatocellular Carcinoma, Residual Small Hepatocellular Carcinoma
Keywords
hepatocellular, Proton, RFA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A(radiofrequency ablation )
Arm Type
Experimental
Arm Description
radiofrequency ablation
Arm Title
B(Proton)
Arm Type
Experimental
Arm Description
hypofractionated proton beam therapy
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
* RFA(radiofrequency ablation ) RFA electrode: Cool-tip RF ablation system (Covidien plc, 20 Lower Hatch Street Dublin 2, Ireland) and Well-Point RF Electrode (STARmed, Koea) performed using either the manufacturer's standard algorithm or an interactive algorithm, with the latter being used when the impedance did not begin to increase at the midinterval of the standard algorithm the duration of a single RFA session was 10 min to 15 min.
Intervention Type
Radiation
Intervention Name(s)
Proton beam therapy
Intervention Description
* Proton 66 GyE /10 fx, 6.6 GyE fraction dose, 5 days/week, for HCC free from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel) (more than 2cm from clinical target volume),TLV30<40%,and/orRLV30<30%)
Primary Outcome Measure Information:
Title
local progression-free survival(LPES)
Description
To evaluate the local progression-free survival for 2 years
Time Frame
up to 2 year
Secondary Outcome Measure Information:
Title
disease-free survival (DFS)
Description
Disease-free survival was defined as the interval from the date of randomization to date of detection study closed
Time Frame
up to 2 years until study closed
Other Pre-specified Outcome Measures:
Title
overall survival (OS)
Description
Overall survival(OS) was defined as the interval from the date of randomization to date of detection study closed
Time Frame
up to 2 years until study closed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joong Won Park, Ph.D
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Korea
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33031846
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.
Results Reference
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Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC

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