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Hepatocellular CarcinomaNCT05433701

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

A study testing Stereotactic Body Radiotherapy and Radiofrequency Ablation in people with Hepatocellular Carcinoma, run by Jonggi Choi at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Stereotactic Body Radiotherapy and Radiofrequency Ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteSouth Korea
Study dates
29 Aug 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: 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.

Read the 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.
Being tested
Stereotactic Body Radiotherapy, Radiofrequency Ablation
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body RadiotherapyRadiation

    • 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 AblationProcedure or surgery

    • 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.
Study groups in NCT05433701
Study groupRoleWhat they receive
RFA groupActive comparator* 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.
Receives: Procedure: Radiofrequency Ablation
SBRT groupExperimentalA total dose of 45 Gy is presecribed using 15 Gy per fraction over 3 consecutive days.
Receives: Radiation: Stereotactic Body Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Local progression-free survival rate, PP

    Measured: At year 2

Secondary outcomes (14)

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

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

    Measured: At year 2

  2. Overall survival rate, ITT

    Overall survival rate, ITT

    Measured: At year 2

  3. Intrahepatic progression-free survival rate, PP

    Intrahepatic progression-free survival rate, PP

    Measured: At year 2

  4. Intrahepatic progression-free survival rate, ITT

    Intrahepatic progression-free survival rate, ITT

    Measured: At year 2

  5. Progression-free survival rate, PP

    Progression-free survival rate, PP

    Measured: At year 2

  6. Progression-free survival rate, ITT

    progression-free survival rate, ITT

    Measured: At year 2

  7. Adverse reaction rate, PP

    Adverse reaction rate, PP

    Measured: At year 2

  8. Adverse reaction rate, ITT

    adverse reaction rate, ITT

    Measured: At year 2

  9. Adverse reaction rate ≥ Gr 3, PP

    Adverse reaction rate ≥ Gr 3, PP

    Measured: At year 2

  10. Adverse reaction rate ≥ Gr 3, ITT

    Adverse reaction rate ≥ Gr 3, ITT

    Measured: At year 2

  11. Change of Child-Pugh score , PP

    Change of Child-Pugh score , PP

    Measured: At year 2

  12. Change of Child-Pugh score, ITT

    Change of Child-Pugh score, ITT

    Measured: At year 2

  13. Local progression-free survival rate according to the tumor location, PP

    Local progression-free survival rate according to the tumor location, PP

    Measured: At year 2

  14. Local progression-free survival rate according to the tumor location, ITT

    Local progression-free survival rate according to the tumor location, ITT

    Measured: At year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start29 Aug 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05433701
Sponsor's protocol ID
STR_1
Status last verified
Aug 2023
First submitted
22 Jun 2022
Last updated
18 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Erratum: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2020 Jul;70(4):313. doi: 10.3322/caac.21609. Epub 2020 Apr 6. No abstract available.

    PubMed 32767693

  • Reig M, Forner A, Rimola J, Ferrer-Fabrega J, Burrel M, Garcia-Criado A, Kelley RK, Galle PR, Mazzaferro V, Salem R, Sangro B, Singal AG, Vogel A, Fuster J, Ayuso C, Bruix J. BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update. J Hepatol. 2022 Mar;76(3):681-693. doi: 10.1016/j.jhep.2021.11.018. Epub 2021 Nov 19.

    PubMed 34801630

  • Lau WY, Lai EC. Salvage surgery following downstaging of unresectable hepatocellular carcinoma--a strategy to increase resectability. Ann Surg Oncol. 2007 Dec;14(12):3301-9. doi: 10.1245/s10434-007-9549-7. Epub 2007 Sep 22.

    PubMed 17891443

  • Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.

    PubMed 16495695

  • Feng K, Yan J, Li X, Xia F, Ma K, Wang S, Bie P, Dong J. A randomized controlled trial of radiofrequency ablation and surgical resection in the treatment of small hepatocellular carcinoma. J Hepatol. 2012 Oct;57(4):794-802. doi: 10.1016/j.jhep.2012.05.007. Epub 2012 May 23.

    PubMed 22634125

  • Huang J, Yan L, Cheng Z, Wu H, Du L, Wang J, Xu Y, Zeng Y. A randomized trial comparing radiofrequency ablation and surgical resection for HCC conforming to the Milan criteria. Ann Surg. 2010 Dec;252(6):903-12. doi: 10.1097/SLA.0b013e3181efc656.

    PubMed 21107100

  • Liu PH, Hsu CY, Hsia CY, Lee YH, Huang YH, Chiou YY, Lin HC, Huo TI. Surgical Resection Versus Radiofrequency Ablation for Single Hepatocellular Carcinoma </= 2 cm in a Propensity Score Model. Ann Surg. 2016 Mar;263(3):538-45. doi: 10.1097/SLA.0000000000001178.

    PubMed 25775062

  • Taguchi H, Sakuhara Y, Hige S, Kitamura K, Osaka Y, Abo D, Uchida D, Sawada A, Kamiyama T, Shimizu T, Shirato H, Miyasaka K. Intercepting radiotherapy using a real-time tumor-tracking radiotherapy system for highly selected patients with hepatocellular carcinoma unresectable with other modalities. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):376-80. doi: 10.1016/j.ijrobp.2007.03.042.

    PubMed 17869660

  • Krishnan S, Dawson LA, Seong J, Akine Y, Beddar S, Briere TM, Crane CH, Mornex F. Radiotherapy for hepatocellular carcinoma: an overview. Ann Surg Oncol. 2008 Apr;15(4):1015-24. doi: 10.1245/s10434-007-9729-5. Epub 2008 Jan 31. No abstract available.

    PubMed 18236114

  • Tse RV, Guha C, Dawson LA. Conformal radiotherapy for hepatocellular carcinoma. Crit Rev Oncol Hematol. 2008 Aug;67(2):113-23. doi: 10.1016/j.critrevonc.2008.01.005. Epub 2008 Mar 4.

    PubMed 18308583

  • Jeong Y, Jung J, Cho B, Kwak J, Jeong C, Kim JH, Park JH, Kim SY, Shim JH, Kim KM, Lim YS, Lee HC, Yoon SM. Stereotactic body radiation therapy using a respiratory-gated volumetric-modulated arc therapy technique for small hepatocellular carcinoma. BMC Cancer. 2018 Apr 13;18(1):416. doi: 10.1186/s12885-018-4340-7.

    PubMed 29653562

  • Takeda A, Sanuki N, Tsurugai Y, Iwabuchi S, Matsunaga K, Ebinuma H, Imajo K, Aoki Y, Saito H, Kunieda E. Phase 2 study of stereotactic body radiotherapy and optional transarterial chemoembolization for solitary hepatocellular carcinoma not amenable to resection and radiofrequency ablation. Cancer. 2016 Jul 1;122(13):2041-9. doi: 10.1002/cncr.30008. Epub 2016 Apr 8.

    PubMed 27062278

  • Su TS, Liang P, Lu HZ, Liang J, Gao YC, Zhou Y, Huang Y, Tang MY, Liang JN. Stereotactic body radiation therapy for small primary or recurrent hepatocellular carcinoma in 132 Chinese patients. J Surg Oncol. 2016 Feb;113(2):181-7. doi: 10.1002/jso.24128. Epub 2015 Dec 14.

    PubMed 26799260

  • Kimura T, Aikata H, Takahashi S, Takahashi I, Nishibuchi I, Doi Y, Kenjo M, Murakami Y, Honda Y, Kakizawa H, Awai K, Chayama K, Nagata Y. Stereotactic body radiotherapy for patients with small hepatocellular carcinoma ineligible for resection or ablation therapies. Hepatol Res. 2015 Apr;45(4):378-86. doi: 10.1111/hepr.12359. Epub 2014 Jun 16.

    PubMed 24849379

  • Takeda A, Sanuki N, Eriguchi T, Kobayashi T, Iwabutchi S, Matsunaga K, Mizuno T, Yashiro K, Nisimura S, Kunieda E. Stereotactic ablative body radiotherapy for previously untreated solitary hepatocellular carcinoma. J Gastroenterol Hepatol. 2014 Feb;29(2):372-9. doi: 10.1111/jgh.12350.

    PubMed 23927053

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Body Radiotherapy and Radiofrequency Ablation in people with Hepatocellular Carcinoma, run by Jonggi Choi at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local progression-free survival rate, per-protocol (PP) (time frame: At year 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05433701, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.

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