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Hepatocellular CarcinomaPhase 2NCT05157451

Y-90 Versus SBRT for Inoperable HCC

A Phase 2 study testing Quality of Life, Questionnaire Administration and Stereotactic Body Radiation Therapy in people with Hepatocellular Carcinoma and Stage I Hepatocellular Carcinoma AJCC v8, run by OHSU Knight Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Quality of Life, Questionnaire Administration and Stereotactic Body Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2023to 5 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine feasibility of trial enrollment (enrollment date).

SECONDARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Quality of Life, Questionnaire Administration, Stereotactic Body Radiation Therapy, Yttrium-90 Microsphere Radioembolization
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality of LifeOther

    Also called QOL, quality of life (QoL), Quality-of-Life

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

  • Yttrium-90 Microsphere RadioembolizationProcedure or surgery

    Also called Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization

    Given via injection

Study groups in NCT05157451
Study groupRoleWhat they receive
Arm I (SBRT)ExperimentalPatients undergo SBRT every other day for a total of 5 days over 2 weeks.
Receives: Other: Quality of Life; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy
Arm II (Y-90 radioembolization)ExperimentalPatients receive Y-90 radioembolization via injection on day 1.
Receives: Other: Quality of Life; Other: Questionnaire Administration; Procedure: Yttrium-90 Microsphere Radioembolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of enrollment (enrollment rate)

    Determine feasibility of trial enrollment for two therapeutic groups.

    Measured: Up to 4 years

Secondary outcomes (8)

  1. Overall survival

    Measured: Death, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, lost to follow up, or 13 months post-treatment

  2. Time to progression

    Measured: 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

  3. Time to intrahepatic progression

    Measured: Time of radiographic intrahepatic progression, adjuvant systemic therapy or liver directed therapy, transplant, death, or 13 months post-treatment

  4. Rate of liver transplant

    Measured: Time of liver transplant, death, or 13 months post-treatment

  5. Rate of non-classic radiation induced liver disease

    Defined as a Child-Pugh criteria >= 2 point increase.

    Measured: Up to 13 months

  6. Rate of patient reported outcome-Common Terminology Criteria for Adverse Events

    Measured: Baseline up to 13 months

  7. Change in patient reported quality of life

    Measured by Functional Assessment of Cancer Therapy-Hepatobilliary Cancer compared to baseline.

    Measured: Baseline to 13 months

  8. Time to next treatment

    Measured: Time to next liver directed or non-adjuvant systemic therapy, transplant, or death, assessed up to 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion5 Jan 2026 (estimated)
  4. Study completion5 Jan 2026 (estimated)

Why it stopped: Not feasible at this time.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157451
Sponsor's protocol ID
STUDY00022029
Other IDs
NCI-2021-11880, STUDY00022029
Status last verified
Mar 2023
First submitted
2 Dec 2021
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quality of Life, Questionnaire Administration and Stereotactic Body Radiation Therapy in people with Hepatocellular Carcinoma and Stage I Hepatocellular Carcinoma AJCC v8, run by OHSU Knight Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of enrollment (enrollment rate) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05157451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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