Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02323360
Status:
TERMINATED
Last Update Posted:
2019-10-25
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
A Randomised Phase III Trial on Stereotactic Body Radiotherapy (SBRT) After Incomplete Transcatheter Arterial Embolization (TAE) or Chemoembolization (TACE) Versus Exclusive TAE or TACE for Inoperable Hepatocellular Carcinoma (HCC)
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
too slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.
Detailed Description:
In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: