Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT03609268
Status:
UNKNOWN
Last Update Posted:
2018-08-01
First Post:
2018-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Effects of Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma: a Prospective, Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prognosis of small liver cancer (≤5 cm) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.
Detailed Description:
Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, group B patients receive SBRT. The 3-year progression free survival, 3-year local recurrence free survival, 3-year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to MWA.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: