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RFA vs. SBRT for Small HCC

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ClinicalTrials.gov Identifier: NCT03898921
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Chen Min-Shan, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation: stereotactic body radiotherapy (SBRT) Procedure: Radiofrequency ablation (RFA) Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation (RFA) Versus Stereotactic Body Radiotherapy (SBRT) for Small Hepatocellular Carcinoma:A Phase III, Prospective, Randomized, Open, Parallel Controlled Clinical Trial
Actual Study Start Date : March 10, 2019
Estimated Primary Completion Date : March 9, 2021
Estimated Study Completion Date : March 8, 2022

Arm Intervention/treatment
Experimental: Stereotactic Body Radiotherapy (SBRT)
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)
Radiotherapy dose is 36-54 Gy, irradiated in 3 times, every other day, completed within 1 week.

Active Comparator: Radiofrequency Ablation (RFA)
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)
RFA with a safe margin, RFA again if residual,no more than 3 times.




Primary Outcome Measures :
  1. 3-year overall survival rate [ Time Frame: From the end of treatment to 3 years ]
    The percentage of alive individuals after three years of follow-up, with death as the primary endpoint.


Secondary Outcome Measures :
  1. 5-year overall survival rate [ Time Frame: From the end of treatment to 5 years ]
    The percentage of alive individuals after five years of follow-up, with death as the primary endpoint.

  2. 1-, 2-, and 3-year progression-free survival rate [ Time Frame: From the end of treatment to 3 years ]
    After 1, 2, and 3 years of follow-up, the percentage of the alive subjects with no signs of tumor progression. Tumor progression was the end point of follow-up. For patients who suffer unexplained death or other anti-tumor treatment were found before tumor progression, the PFS calculation is up to this point. Determination of tumor progression is based on imaging examination (CT or MRI), and the evaluation criteria refers to the mRECIST criteria.

  3. Local control rate [ Time Frame: From the end of treatment to 5 years ]
    after long-term follow-up, the percentage of the alive subjects with no signs of local tumor progression. The local tumor progression is the end point of follow-up. Definition of local tumor progression is based on imaging examination (CT or MRI), and the evaluation criteria refers to the mRECIST criteria.

  4. Safety profile: incidence of complications [ Time Frame: 30 days after the end of treatment ]
    The safety of the treatment was evaluated by the incidence of complications. Acute complications are defined as the occurrence of adverse events within 30 days of treatment; long-term complications are defined as the occurrence of adverse events 30 days after the end of treatment. Adverse events are defined in accordance with the NCI CTC AE 4.0 standard.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Single tumor≤5cm in diameter with no vascular invasion, lymph node or distant metastasis.
  3. 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.
  4. No contraindications to RFA and SBRT treatment.
  5. KPS≥90.
  6. Liver function: Child-Pugh class A; normal liver volume is more than 800cm3.
  7. The expected survival of the patient is more than 6 months.
  8. 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.

  9. Agree to accept postoperative follow-up required by the design of this study.
  10. 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.

Exclusion Criteria:

  1. 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.
  2. Patients have a history of other malignancies.
  3. Patients have a history of allergic reactions to related drugs.
  4. Patients have a history of organ transplantation.
  5. Pregnant women, nursing mothers.
  6. Patients cannot be performed RFA or SBRT treatment.
  7. Patients have other factors that may affect patient enrollment and assessment results.
  8. Receiving immunotherapy or targeted therapy.
  9. Refuse the follow-up regulations as required by this study protocol and refuse to sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898921


Contacts
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Contact: Zhang Yao-Jun, MD. PHD. +8613719433968 ext 86-20-87343585 zhangyuj@sysucc.org.cn
Contact: XI MIAN, MD. +8613826230571 ext 86-20-87343117 ximian@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: ZHANG YAOJUN, MD.    +8613719433968 ext +862087343585    zhangyj@sysucc.org.cn   
Contact: XI MIAN, MD.    +8613826230571 ext +862087343117    ximian@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: ZHANG YAOJUN, MD. Sun Yat-sen University

Publications:

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Responsible Party: Chen Min-Shan, Clinical Pro., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03898921     History of Changes
Other Study ID Numbers: RFA versus SBRT in SYSUCC
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chen Min-Shan, Sun Yat-sen University:
Small Hepatocellular Carcinoma
Radiofrequency Ablation
Stereotactic Body Radiotherapy

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases