Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243841
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2005-10-21
Brief Title:
Dose Escalation Study for Primary Hepatocellular Carcinoma
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Multi-institution Phase III Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
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:
SBF-HCC
Brief Summary:
The purpose of this study is to determine the maximum tolerated dose of limited fractions of large dose radiation in an effort to achieve a biologically potent cancer therapy in selected patients with primary hepatocellular carcinoma
Detailed Description:
Despite recent advances in early detection and diagnosis only 30-40 of patients with hepatocellular carcinoma may benefit from radical therapies Liver transplantation offers the best chance for cure Surgical resection has been the only other potentially curative option but the majority of patients are not candidates for resection This reflects the usual comorbidity of severe underlying liver disease that either precludes surgery or makes the surgical approach extremely dangerous
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?:
None