RFA vs. SBRT for Small HCC

NCT03898921 | Unknown Phase 3 DMC

• 1 other identifier: RFA versus SBRT in SYSUCC
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Hepatocellular Carcinoma

Keywords

Small Hepatocellular Carcinoma; Radiofrequency Ablation; Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival rate

  The percentage of alive individuals after three years of follow-up, with death as the primary endpoint.

  From the end of treatment to 3 years

Secondary Outcomes (4)

• 5-year overall survival rate

  From the end of treatment to 5 years

• 1-, 2-, and 3-year progression-free survival rate

  From the end of treatment to 3 years

• Local control rate

  From the end of treatment to 5 years

• Safety profile: incidence of complications

  30 days after the end of treatment

Other Outcomes (2)

• Tumor response after radiotherapy

  From the end of treatment to 2 years

• Radiation-induced liver injury

  From the end of treatment to 1 years

Study Arms (2)

Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

The planned target volume (PTV) was constructed by adding a 5-mm geometric uncertainty margin around the clinical target volume (CTV). The dose-volume constraints used during SBRT planning are fairly standardized: care was taken to ensure that at least 700 cm3 of normal liver parenchyma was exposed to \<15 Gy over the course of SBRT, consistent with published recommendation. Radiotherapy dose was prescribed to the isodose surface covering 99.5% of the PTV, typically 75% to 85% of the maximum PTV dose, accepting regional underdosing when necessary to satisfy normal tissue limits.

Radiation: stereotactic body radiotherapy (SBRT)

Radiofrequency Ablation (RFA)

ACTIVE COMPARATOR

Radiofrequency Ablation is carried out under intravenous anesthesia/epidural anesthesia/general anesthesia, with CT or B-ultrasound guidance, through percutaneous or laparoscopic means as far as possible. The ablation range requires complete coverage of the tumor, and has a certain "safe margin". CT/MRI/sonography will be performed 1 month after RFA. If residual tumor was found after treatment, RFA will be carried out again. If there are still residual tumor after two or more RFA treatments, the RFA treatment will be stopped. After the local progression of the tumor, surgical treatment or other treatment methods are considered according to the specific condition.

Procedure: Radiofrequency ablation (RFA)

Interventions

stereotactic body radiotherapy (SBRT) RADIATION

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

Stereotactic Body Radiotherapy (SBRT)

Radiofrequency ablation (RFA) PROCEDURE

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

Radiofrequency Ablation (RFA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated hepatocellular carcinoma; the diagnostic criteria are based on the "Diagnostic Criteria for Liver Cancer" in the 2017 edition of the "Diagnosis and Treatment of Primary Liver Cancer" by the Department of Health and Medical Administration of the Ministry of Health of China.
• Single tumor≤5cm in diameter with no vascular invasion, lymph node or distant metastasis.
• Central type of liver cancer: the shortest distance between tumor and hepatic vein, portal vein, biliary system trunk or first or second branch, or the posterior inferior vena cava of the liver is no more than 1.0cm.
• No contraindications to RFA and SBRT treatment.
• KPS≥90.
• Liver function: Child-Pugh class A; normal liver volume is more than 800cm3.
• The expected survival of the patient is more than 6 months.
• The following conditions are met:
• Platelet≥70×109/L; White blood cell≥3.0×109/L; Hemoglobin≥85 g/L; Serum creatinine≤1.5 × upper limit; PT≤3 second extension.
• Agree to accept postoperative follow-up required by the design of this study.
• Patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study.

You may not qualify if:

• In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases (\> CTCAE Version 3.0 adverse events of grade 2), that can not tolerate treatment.
• Patients have a history of other malignancies.
• Patients have a history of allergic reactions to related drugs.
• Patients have a history of organ transplantation.
• Pregnant women, nursing mothers.
• Patients cannot be performed RFA or SBRT treatment.
• Patients have other factors that may affect patient enrollment and assessment results.
• Receiving immunotherapy or targeted therapy.
• Refuse the follow-up regulations as required by this study protocol and refuse to sign informed consent.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (13)

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• Ng KKC, Chok KSH, Chan ACY, Cheung TT, Wong TCL, Fung JYY, Yuen J, Poon RTP, Fan ST, Lo CM. Randomized clinical trial of hepatic resection versus radiofrequency ablation for early-stage hepatocellular carcinoma. Br J Surg. 2017 Dec;104(13):1775-1784. doi: 10.1002/bjs.10677. Epub 2017 Nov 1.

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  PMID: 22190656 BACKGROUND

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  PMID: 15690326 BACKGROUND

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• 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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  PMID: 23547075 BACKGROUND

• Yoon SM, Lim YS, Park MJ, Kim SY, Cho B, Shim JH, Kim KM, Lee HC, Chung YH, Lee YS, Lee SG, Lee YS, Park JH, Kim JH. Stereotactic body radiation therapy as an alternative treatment for small hepatocellular carcinoma. PLoS One. 2013 Nov 8;8(11):e79854. doi: 10.1371/journal.pone.0079854. eCollection 2013.

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• Sanuki N, Takeda A, Oku Y, Mizuno T, Aoki Y, Eriguchi T, Iwabuchi S, Kunieda E. Stereotactic body radiotherapy for small hepatocellular carcinoma: a retrospective outcome analysis in 185 patients. Acta Oncol. 2014 Mar;53(3):399-404. doi: 10.3109/0284186X.2013.820342. Epub 2013 Aug 21.

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  PMID: 24849379 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Radiofrequency Therapy; Ablation Techniques

Study Officials

• ZHANG YAOJUN, MD.

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Zhang Yao-Jun, MD. PHD.

CONTACT

+8613719433968; zhangyuj@sysucc.org.cn

XI MIAN, MD.

CONTACT

+8613826230571; ximian@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pro.

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 2, 2019
• Study Start: March 10, 2019
• Primary Completion: March 9, 2021
• Study Completion: March 8, 2022
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

CN (1)