Stereotactic Body Radiotherapy Versus Radiofrequency Ablation for Unresectable, Small (≤ 3 cm) HCC
NCT ID: NCT05433701
Last Updated: 2023-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
178 participants
INTERVENTIONAL
2022-08-29
2026-12-31
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
SBRT group
A total dose of 45 Gy is presecribed using 15 Gy per fraction over 3 consecutive days.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Jonggi Choi
OTHER
Responsible Party
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Jonggi Choi
Professor
Principal Investigators
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Jonggi Choi, M.D, Ph D
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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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.
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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.
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.
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.
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.
Jung J, Yoon SM, Kim SY, Cho B, Park JH, Kim SS, Song SY, Lee SW, Ahn SD, Choi EK, Kim JH. Radiation-induced liver disease after stereotactic body radiotherapy for small hepatocellular carcinoma: clinical and dose-volumetric parameters. Radiat Oncol. 2013 Oct 27;8:249. doi: 10.1186/1748-717X-8-249.
Andolino DL, Johnson CS, Maluccio M, Kwo P, Tector AJ, Zook J, Johnstone PA, Cardenes HR. Stereotactic body radiotherapy for primary hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e447-53. doi: 10.1016/j.ijrobp.2011.04.011. Epub 2011 Jun 7.
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Rhim H, Yoon KH, Lee JM, Cho Y, Cho JS, Kim SH, Lee WJ, Lim HK, Nam GJ, Han SS, Kim YH, Park CM, Kim PN, Byun JY. Major complications after radio-frequency thermal ablation of hepatic tumors: spectrum of imaging findings. Radiographics. 2003 Jan-Feb;23(1):123-34; discussion 134-6. doi: 10.1148/rg.231025054.
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Other Identifiers
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STR_1
Identifier Type: -
Identifier Source: org_study_id
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