Trials / Withdrawn
WithdrawnNCT05157451
Y-90 Versus SBRT for Inoperable HCC
Randomized Prospective Two-Arm Feasibility Trial of Stereotactic Body Radiation Therapy Versus Yttrium-90 Segmentectomy in Inoperable Hepatocellular Carcinoma
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- OHSU Knight Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Hepatocellular Carcinoma
- Stage I Hepatocellular Carcinoma AJCC v8
- Stage IA Hepatocellular Carcinoma AJCC v8
- Stage IB Hepatocellular Carcinoma AJCC v8
- Stage II Hepatocellular Carcinoma AJCC v8
- Stage III Hepatocellular Carcinoma AJCC v8
- Stage IIIA Hepatocellular Carcinoma AJCC v8
- Stage IIIB Hepatocellular Carcinoma AJCC v8
- Stage IVA Hepatocellular Carcinoma AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Quality of Life | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
| RADIATION | Stereotactic Body Radiation Therapy | Undergo SBRT |
| PROCEDURE | Yttrium-90 Microsphere Radioembolization | Given via injection |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2026-01-05
- Completion
- 2026-01-05
- First posted
- 2021-12-15
- Last updated
- 2023-03-23
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05157451. Inclusion in this directory is not an endorsement.