Y-90 Versus SBRT for Inoperable HCC

March 21, 2023 updated by: Nima Nabavizadeh, OHSU Knight Cancer Institute

Randomized Prospective Two-Arm Feasibility Trial of Stereotactic Body Radiation Therapy Versus Yttrium-90 Segmentectomy in Inoperable Hepatocellular Carcinoma

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Knight Cancer Institute
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent document.
  • 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:

  • Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (SBRT)
Patients undergo SBRT every other day for a total of 5 days over 2 weeks.
Other: Questionnaire Administration
Ancillary studies
Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SBRT
  • SABR
  • Stereotactic Ablative Body Radiation Therapy
Other: Quality of Life
Ancillary studies
Other Names:
  • QOL
  • quality of life (QoL)
  • Quality-of-Life
Experimental: Arm II (Y-90 radioembolization)
Patients receive Y-90 radioembolization via injection on day 1.
Other: Questionnaire Administration
Ancillary studies
Other: Quality of Life
Ancillary studies
Other Names:
  • QOL
  • quality of life (QoL)
  • Quality-of-Life
Procedure: Yttrium-90 Microsphere Radioembolization
Given via injection
Other Names:
  • Yttrium Y 90 Microsphere Therapy
  • Yttrium-90 Radioembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of enrollment (enrollment rate)
Time Frame: Up to 4 years
Determine feasibility of trial enrollment for two therapeutic groups.
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Death, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, lost to follow up, or 13 months post-treatment
Death, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, lost to follow up, or 13 months post-treatment
Time to progression
Time Frame: Time of radiographic evidence of treated tumor progression as determined by tumor board review, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, death, or 13 months post-treatment
Time of radiographic evidence of treated tumor progression as determined by tumor board review, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, death, or 13 months post-treatment
Time to intrahepatic progression
Time Frame: Time of radiographic intrahepatic progression, adjuvant systemic therapy or liver directed therapy, transplant, death, or 13 months post-treatment
Time of radiographic intrahepatic progression, adjuvant systemic therapy or liver directed therapy, transplant, death, or 13 months post-treatment
Rate of liver transplant
Time Frame: Time of liver transplant, death, or 13 months post-treatment
Time of liver transplant, death, or 13 months post-treatment
Rate of non-classic radiation induced liver disease
Time Frame: Up to 13 months
Defined as a Child-Pugh criteria >= 2 point increase.
Up to 13 months
Rate of patient reported outcome-Common Terminology Criteria for Adverse Events
Time Frame: Baseline up to 13 months
Baseline up to 13 months
Change in patient reported quality of life
Time Frame: Baseline to 13 months
Measured by Functional Assessment of Cancer Therapy-Hepatobilliary Cancer compared to baseline.
Baseline to 13 months
Time to next treatment
Time Frame: Time to next liver directed or non-adjuvant systemic therapy, transplant, or death, assessed up to 13 months
Time to next liver directed or non-adjuvant systemic therapy, transplant, or death, assessed up to 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University
American Society of Clinical Oncology
Radiological Society of North America
Medical Research Foundation, Oregon
Radiation Oncology Institute

Investigators

  • Principal Investigator: Nima Nabavizadeh, OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

January 5, 2026

Study Completion (Anticipated)

January 5, 2026

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00022029 (Other Identifier: OHSU Knight Cancer Institute)
  • NCI-2021-11880 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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