NCT05433701Active, not recruiting
Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) HCC
A Phase III Randomized Controlled Non-inferiority Trial to Compare Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 18 Aug 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 178 (actual)
- First submitted
- 22 Jun 2022
- Start date
- 29 Aug 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Jonggi Choi
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05433701
What you commit to
- Study type: Interventional
- Participants enrolled: 178
- From 29 Aug 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous history of liver transplantation
- an active gastric or duodenal ulcer within 3 months before screening
Other illness
- uncontrolled ascites, variceal bleeding, or hepatic encephalopathy
- uncontrolled other malignancies except for HCC within 2 years before screening
Lab values
- platelet count \<50,000/µl
Other
- Eastern Cooperative Oncology Group performance status score 3 or 4
- pregnant woman
- Patients who are judged by the researcher to be difficult to conduct clinical research
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.