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NCT Number: NCT05433701

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

stereotactic body radiotherapy

Radiation
  • 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.

Radiofrequency ablation

Procedure
  • 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.

Primary outcomes

  1. Local progression-free survival rate, per-protocol (PP)

    Time frame: At year 2

    Local progression-free survival rate, PP

Secondary outcomes

  1. Progression-free survival rate, intention-to-treat (ITT)

    Time frame: At year 2

    Progression-free survival rate, intention-to-treat (ITT)

  2. Overall survival rate, ITT

    Time frame: At year 2

    Overall survival rate, ITT

  3. Intrahepatic progression-free survival rate, PP

    Time frame: At year 2

    Intrahepatic progression-free survival rate, PP

  4. Intrahepatic progression-free survival rate, ITT

    Time frame: At year 2

    Intrahepatic progression-free survival rate, ITT

  5. Progression-free survival rate, PP

    Time frame: At year 2

    Progression-free survival rate, PP

  6. Progression-free survival rate, ITT

    Time frame: At year 2

    progression-free survival rate, ITT

  7. Adverse reaction rate, PP

    Time frame: At year 2

    Adverse reaction rate, PP

  8. Adverse reaction rate, ITT

    Time frame: At year 2

    adverse reaction rate, ITT

  9. Adverse reaction rate ≥ Gr 3, PP

    Time frame: At year 2

    Adverse reaction rate ≥ Gr 3, PP

  10. Adverse reaction rate ≥ Gr 3, ITT

    Time frame: At year 2

    Adverse reaction rate ≥ Gr 3, ITT

  11. Change of Child-Pugh score , PP

    Time frame: At year 2

    Change of Child-Pugh score , PP

  12. Change of Child-Pugh score, ITT

    Time frame: At year 2

    Change of Child-Pugh score, ITT

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Jonggi Choi

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2022
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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