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

NCT01963429 | Completed

• 1 other identifier: NCCCTS 13-695
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Small Hepatocellular Carcinoma; Residual Small Hepatocellular Carcinoma

Keywords

hepatocellular; Proton; RFA

Outcome Measures

Primary Outcomes (1)

• local progression-free survival(LPES)

  To evaluate the local progression-free survival for 2 years

  up to 2 year

Secondary Outcomes (1)

• disease-free survival (DFS)

  up to 2 years until study closed

Other Outcomes (1)

• overall survival (OS)

  up to 2 years until study closed

Study Arms (2)

A(radiofrequency ablation )

EXPERIMENTAL

radiofrequency ablation

Procedure: radiofrequency ablation

B(Proton)

EXPERIMENTAL

hypofractionated proton beam therapy

Radiation: Proton beam therapy

Interventions

radiofrequency ablation PROCEDURE

\* 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.

A(radiofrequency ablation )

Proton beam therapy RADIATION

\* 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%)

B(Proton)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33031846 DERIVED

MeSH Terms

Interventions

Radiofrequency Ablation; Proton Therapy

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Heavy Ion Radiotherapy; Radiotherapy

Study Officials

• Joong Won Park, Ph.D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2013
• First Posted: October 16, 2013
• Study Start: September 30, 2013
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

KR (1)