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
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Radiation: stereotactic body radiotherapy (SBRT) Procedure: Radiofrequency ablation (RFA)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898921
|Contact: Zhang Yao-Jun, MD. PHD.||+8613719433968 ext firstname.lastname@example.org|
|Contact: XI MIAN, MD.||+8613826230571 ext email@example.com|
|Study Chair:||ZHANG YAOJUN, MD.||Sun Yat-sen University|