Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-12-01
2026-01-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
SINGLE
Study Groups
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Arm I (SBRT)
Patients undergo SBRT every other day for a total of 5 days over 2 weeks.
Quality of Life
Ancillary studies
Questionnaire Administration
Ancillary studies
Stereotactic Body Radiation Therapy
Undergo SBRT
Arm II (Y-90 radioembolization)
Patients receive Y-90 radioembolization via injection on day 1.
Quality of Life
Ancillary studies
Questionnaire Administration
Ancillary studies
Yttrium-90 Microsphere Radioembolization
Given via injection
Interventions
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Quality of Life
Ancillary studies
Questionnaire Administration
Ancillary studies
Stereotactic Body Radiation Therapy
Undergo SBRT
Yttrium-90 Microsphere Radioembolization
Given via injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years at time of informed consent. Both men and women and members of all races and ethnic groups will be included.
* Patient with non-metastatic hepatocellular carcinoma (HCC) including lesion(s) amenable to definitive therapy with either SBRT or Y-90 segmentectomy, limited to =\< 2 liver segments, as agreed upon by the multidisciplinary tumor board consensus.
* Patient not otherwise optimal candidates for resection or thermal ablation, as agreed upon by the multidisciplinary tumor board.
* Have a Child-Pugh criteria (CP) score B7 or better.
* Eastern Clinical Oncology Group (ECOG) performance status =\< 1, or Karnofsky performance scale \> 70.
* No other prior invasive malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years.
Exclusion Criteria
* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, serious or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent.
18 Years
ALL
No
Sponsors
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American Society of Clinical Oncology
OTHER
Medical Research Foundation, Oregon
OTHER
Oregon Health and Science University
OTHER
Radiation Oncology Institute
UNKNOWN
Radiological Society of North America
OTHER
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Nima Nabavizadeh
Principal Investigator
Principal Investigators
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Nima Nabavizadeh
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Other Identifiers
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NCI-2021-11880
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00022029
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00022029
Identifier Type: -
Identifier Source: org_study_id
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