Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-03 @ 5:11 AM
Study NCT ID:
NCT05157451
Status:
WITHDRAWN
Last Update Posted:
2023-03-23
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Y-90 Versus SBRT for Inoperable HCC
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Randomized Prospective Two-Arm Feasibility Trial of Stereotactic Body Radiation Therapy Versus Yttrium-90 Segmentectomy in Inoperable Hepatocellular Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not feasible at this time.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests whether Y-90 segmentectomy (internal radiation) versus stereotactic body radiation therapy (external radiation) is more optimal in treating inoperable liver cancer. Y-90 segmentectomy consists into very tiny radioactive glass beads that can be injected into the liver through the blood vessels supplying the liver. Stereotactic body radiation therapy uses special equipment to position a patient and deliver external radiation to tumors with high precision. This study many help doctors determine which treatment, Y-90 segmentectomy or SBRT, works better in treating liver cancer.
Detailed Description:
PRIMARY OBJECTIVE:
I. Determine feasibility of trial enrollment (enrollment date).
SECONDARY OBJECTIVE:
I. To assess differences in overall survival, local control, time to intrahepatic progression, time to next treatment, rate of liver transplant, toxicity, and patient reported complications and quality of life.
EXPLORATORY OBJECTIVE:
I. Compare cumulative cost of treatment-related medical care at 13 months.
OUTLINE: Patients will be randomized in 1 of 2 arms.
Arm I: Patients undergo SBRT every other day for a total of 5 days over 2 weeks.
Arm II: Patients receive Y-90 radioembolization via injection on day 1.
After completion of study, patients are followed up at 2, 4, and 12 weeks and then every 3 months for 13 months.
I. Determine feasibility of trial enrollment (enrollment date).
SECONDARY OBJECTIVE:
I. To assess differences in overall survival, local control, time to intrahepatic progression, time to next treatment, rate of liver transplant, toxicity, and patient reported complications and quality of life.
EXPLORATORY OBJECTIVE:
I. Compare cumulative cost of treatment-related medical care at 13 months.
OUTLINE: Patients will be randomized in 1 of 2 arms.
Arm I: Patients undergo SBRT every other day for a total of 5 days over 2 weeks.
Arm II: Patients receive Y-90 radioembolization via injection on day 1.
After completion of study, patients are followed up at 2, 4, and 12 weeks and then every 3 months for 13 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: