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RFA vs. SBRT for Small HCC

NCT03898921 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2020-11-24

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is one of the malignant tumors that seriously threaten the health of people. Its morbidity and mortality rank the third and the second among various malignant tumors in China, respectively. Local ablation therapy represented by radiofrequency ablation (RFA) has been recommended as a first-line treatment for small HCC by most international guidelines. Especially for central small HCC, RFA is considered the first-line choice. With the advancement of radiotherapy equipment and the development of precise imaging technology, stereotactic body radiotherapy (SBRT) has become one of the important treatments for liver cancer.Retrospective controlled studies have shown that SBRT is similar to RFA in treating small HCC, and the local control rate may be better than RFA. But there is no high-level evidence to support which treatment is superior. This project aims to conduct a phase III, prospective, randomized, open, parallel controlled clinical study of RFA versus SBRT for small HCC (solitary tumor≤ 5.0 cm). The results will provide potent evidence for the rational and effective treatment of early HCC and the improvement of clinical guidelines for HCC.

Conditions

Interventions

RADIATION

stereotactic body radiotherapy (SBRT)

Radiotherapy dose is 36-54 Gy, irradiated in 3 times, every other day, completed within 1 week.

PROCEDURE

Radiofrequency ablation (RFA)

RFA with a safe margin, RFA again if residual,no more than 3 times.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • ZHANG YAOJUN, MD. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-10
Primary Completion
2021-03-09
Completion
2022-03-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03898921 on ClinicalTrials.gov