Ignite Creation Date:
2025-12-18 @ 6:33 AM
Ignite Modification Date:
2025-12-23 @ 10:47 PM
Study NCT ID:
NCT00746655
Status:
None
Last Update Posted:
2015-12-24 00:00:00
First Post:
2008-09-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SBRT + TACE for Primary Hepatocellular Carcinoma
Sponsor:
None
Organization:
Study Overview
Official Title:
A Study of Stereotactic Body Radiation Therapy (SBRT) in Combination With Cisplatin Transcatheter Arterial Chemoembolization (TACE) for Primary Hepatocellular Carcinoma (HCC)
Status:
None
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who are poor surgical candidates could potentially benefit from non-surgical alternatives such as stereotactic body radiation therapy (SBRT). SBRT is an ideal approach to minimize radiation exposure to the normal liver while maximizing the dose to the tumor. Transarterial chemoembolization (TACE) is the combined use of intra-arterial chemotherapy and particulate arterial embolization. This technique is typically used to make unresectable liver lesions amenable to resection, for palliation in cases of extra-hepatic spread or recurrence, or for symptomatic relief. The combination of intraarterial chemotherapy with vessel embolization makes logical sense since primary and secondary liver tumors derive up to 95% of their blood supply from the hepatic artery, while the normal liver gains the majority of its blood supply from the portal system. Thus, using transarterial chemoembolization it is possible to achieve high intratumor drug concentrations followed by local ischemia, allowing uninvolved liver to be spared. This study is to determine that these standard of care therapies combined to improve the quality of life for the patient population.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: