Back to results

Y-90 Versus SBRT for Inoperable HCC

Primary Purpose

Hepatocellular Carcinoma, Stage I Hepatocellular Carcinoma AJCC v8, Stage IA Hepatocellular Carcinoma AJCC v8

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Quality of Life

Questionnaire Administration

Stereotactic Body Radiation Therapy

Yttrium-90 Microsphere Radioembolization

About this trial

This is an interventional device feasibility trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I (SBRT)

Arm II (Y-90 radioembolization)

Arm Description

Patients undergo SBRT every other day for a total of 5 days over 2 weeks.

Patients receive Y-90 radioembolization via injection on day 1.

Outcomes

Primary Outcome Measures

Feasibility of enrollment (enrollment rate)

Determine feasibility of trial enrollment for two therapeutic groups.

Secondary Outcome Measures

Overall survival

Time to progression

Time to intrahepatic progression

Rate of liver transplant

Rate of non-classic radiation induced liver disease

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

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

Change in patient reported quality of life

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

Time to next treatment

Full Information

NCT ID

NCT05157451

First Posted

December 2, 2021

Last Updated

March 21, 2023

Sponsor

OHSU Knight Cancer Institute

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05157451

Brief Title

Y-90 Versus SBRT for Inoperable HCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Not feasible at this time.

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

January 5, 2026 (Anticipated)

Study Completion Date

January 5, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (SBRT)

Arm Type

Experimental

Arm Description

Patients undergo SBRT every other day for a total of 5 days over 2 weeks.

Arm Title

Arm II (Y-90 radioembolization)

Arm Type

Experimental

Arm Description

Patients receive Y-90 radioembolization via injection on day 1.

Intervention Type

Other

Intervention Name(s)

Quality of Life

Other Intervention Name(s)

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

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy

Other Intervention Name(s)

SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Intervention Description

Undergo SBRT

Intervention Type

Procedure

Intervention Name(s)

Yttrium-90 Microsphere Radioembolization

Other Intervention Name(s)

Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization

Intervention Description

Given via injection

Primary Outcome Measure Information:

Title

Feasibility of enrollment (enrollment rate)

Description

Determine feasibility of trial enrollment for two therapeutic groups.

Time Frame

Up to 4 years

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

Rate of liver transplant

Time Frame

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

Title

Rate of non-classic radiation induced liver disease

Description

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

Time Frame

Up to 13 months

Title

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

Time Frame

Baseline up to 13 months

Title

Change in patient reported quality of life

Description

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

Time Frame

Baseline to 13 months

Title

Time to next treatment

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nima Nabavizadeh

Organizational Affiliation

OHSU Knight Cancer Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Y-90 Versus SBRT for Inoperable HCC

We'll reach out to this number within 24 hrs