Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) HCC

August 15, 2023 updated by: Jonggi Choi

A Phase III Randomized Controlled Non-inferiority Trial to Compare Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related mortality and the sixth most prevalent cancer in the world. Standard treatments for early-stage HCCs include resection, liver transplantation, and percutaneous ablation, with 5-year survival rates of over 50 percent. Less than one-third of patients, however, are candidates for hepatic resection, and the use of radiofrequency ablation (RFA) may be significantly limited in cases with unfavorable tumor location and poor visibility on images, which increase the risk of technical failures and complications after RFA.

Recent advancements in radiotherapy and imaging have made it possible to deliver optimal radiation doses on the tumor site while minimizing exposure to normal organs. Stereotactic body radiation therapy (SBRT) is a method of high-precision radiation therapy that concentrates high-dose radiation to HCC in a short period of time to maximize the therapeutic effect on the tumor and minimize the side effects on normal tissues. Prospective and retrospective studies on SBRT for HCC have demonstrated its efficacy for local tumor control in small HCC. On the basis of these promising clinical results, a number of studies have compared the efficacy of RFA and SBRT. However, there is no strong evidence from randomized controlled trials comparing SBRT and RFA.

In order to evaluate and compare the local efficacy and clinical outcomes of SBRT and RFA in patients with recurrent HCC, we conduct this non-inferiority trial.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of 178 subjects are randomly assigned to one of two treatment groups (89 patients in the body stereotactic radiotherapy group and 89 patients in the radiofrequency ablation group). If the assigned treatment method is technically infeasible, patients are allowed to be treated with the other method.

  • RFA: When localization of the lesion is difficult under image guidance, when it is difficult to secure a safe needle path, when there is a risk of collateral thermal damage to adjacent organs, and when it is difficult to prevent it.
  • SBRT: When irradiation with 45 Gy (daily dose of 15 Gy) is infeasible due to the maximum tolerance dose of normal organs.

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patient over the age of 18
  2. primary or recurrent HCC that is not suitable for surgery
  3. HCCs with a longest diameter of ≤3cm and ≤2 lesions
  4. no evidence of intrahepatic or extrahepatic residual disease except for target lesions
  5. Child-Pugh class A or B hepatic function
  6. no macroscopic vascular invasion or extrahepatic metastasis
  7. written informed consent

Exclusion Criteria:

  1. Eastern Cooperative Oncology Group performance status score 3 or 4
  2. uncontrolled ascites, variceal bleeding, or hepatic encephalopathy
  3. previous history of liver transplantation
  4. an active gastric or duodenal ulcer within 3 months before screening
  5. pregnant woman
  6. uncontrolled other malignancies except for HCC within 2 years before screening
  7. platelet count <50,000/µl
  8. Patients who are judged by the researcher to be difficult to conduct clinical research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RFA group
  • RFA are performed under local anesthesia or monitored anesthesia care with either a 15-gause or 17-gause internally cooled electrode, depending on the size of the tumor.
  • RFA procedures are continued by modifying the output power based on the location and size of the tumor until the entire tumor and border area sizes of greater than 0.5 cm are included in the detected target lesion on ultrasound or CT.
Procedure: Radiofrequency Ablation
- RFA are performed under local anesthesia or monitored anesthesia care with either a 15-gause or 17-gause internally cooled electrode, depending on the size of the tumor.
Experimental: SBRT group
A total dose of 45 Gy is presecribed using 15 Gy per fraction over 3 consecutive days.
Radiation: Stereotactic Body Radiotherapy
  • Verify the setup position and respiration of patients as in the simulation CT image.
  • To precisely align the tumor prior to each treatment, cone-beam CT and gated fluoroscopy using the On-board Imager mounted on the linear accelerator are performed.
  • The Real-time Position Management system is used to monitor the accuracy of breathing phase during treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local progression-free survival rate, per-protocol (PP)
Time Frame: At year 2
Local progression-free survival rate, PP
At year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival rate, intention-to-treat (ITT)
Time Frame: At year 2
Progression-free survival rate, intention-to-treat (ITT)
At year 2
Overall survival rate, ITT
Time Frame: At year 2
Overall survival rate, ITT
At year 2
Intrahepatic progression-free survival rate, PP
Time Frame: At year 2
Intrahepatic progression-free survival rate, PP
At year 2
Intrahepatic progression-free survival rate, ITT
Time Frame: At year 2
Intrahepatic progression-free survival rate, ITT
At year 2
Progression-free survival rate, PP
Time Frame: At year 2
Progression-free survival rate, PP
At year 2
Progression-free survival rate, ITT
Time Frame: At year 2
progression-free survival rate, ITT
At year 2
Adverse reaction rate, PP
Time Frame: At year 2
Adverse reaction rate, PP
At year 2
Adverse reaction rate, ITT
Time Frame: At year 2
adverse reaction rate, ITT
At year 2
Adverse reaction rate ≥ Gr 3, PP
Time Frame: At year 2
Adverse reaction rate ≥ Gr 3, PP
At year 2
Adverse reaction rate ≥ Gr 3, ITT
Time Frame: At year 2
Adverse reaction rate ≥ Gr 3, ITT
At year 2
Change of Child-Pugh score , PP
Time Frame: At year 2
Change of Child-Pugh score , PP
At year 2
Change of Child-Pugh score, ITT
Time Frame: At year 2
Change of Child-Pugh score, ITT
At year 2
Local progression-free survival rate according to the tumor location, PP
Time Frame: At year 2
Local progression-free survival rate according to the tumor location, PP
At year 2
Local progression-free survival rate according to the tumor location, ITT
Time Frame: At year 2
Local progression-free survival rate according to the tumor location, ITT
At year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonggi Choi

Investigators

  • Principal Investigator: Jonggi Choi, M.D, Ph D, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STR_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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