Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT01899261
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2013-07-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
Albert Einstein College of Medicine
Organization:
Study Overview
Official Title:
A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2022-11
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:
None
Brief Summary:
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).
SECONDARY OBJECTIVES:
I. To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.
II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.
III. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.
OUTLINE:
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.
I. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).
SECONDARY OBJECTIVES:
I. To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.
II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.
III. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.
OUTLINE:
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-326 | OTHER | Albert Einstein College of Medicine | View | |
| P30CA013330 | NIH | None | https://reporter.nih.gov/quic… | View |