Y-90 Versus SBRT for Inoperable HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05157451
• Other study ID #: STUDY00022029
• Secondary ID: NCI-2021-11880ST
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: January 5, 2026

Study information

• Verified date: March 2023
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 5, 2026
• Est. primary completion date: January 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• 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

Intervention

Other:
• Quality of Life
Ancillary studies
• Questionnaire Administration
Ancillary studies

Radiation:
• Stereotactic Body Radiation Therapy
Undergo SBRT

Procedure:
• Yttrium-90 Microsphere Radioembolization
Given via injection

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	American Society of Clinical Oncology, Medical Research Foundation, Oregon, Oregon Health and Science University, Radiation Oncology Institute, Radiological Society of North America

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of enrollment (enrollment rate)	Determine feasibility of trial enrollment for two therapeutic groups.	Up to 4 years
Secondary	Overall survival		Death, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, lost to follow up, or 13 months post-treatment
Secondary	Time to progression		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
Secondary	Time to intrahepatic progression		Time of radiographic intrahepatic progression, adjuvant systemic therapy or liver directed therapy, transplant, death, or 13 months post-treatment
Secondary	Rate of liver transplant		Time of liver transplant, death, or 13 months post-treatment
Secondary	Rate of non-classic radiation induced liver disease	Defined as a Child-Pugh criteria >= 2 point increase.	Up to 13 months
Secondary	Rate of patient reported outcome-Common Terminology Criteria for Adverse Events		Baseline up to 13 months
Secondary	Change in patient reported quality of life	Measured by Functional Assessment of Cancer Therapy-Hepatobilliary Cancer compared to baseline.	Baseline to 13 months
Secondary	Time to next treatment		Time to next liver directed or non-adjuvant systemic therapy, transplant, or death, assessed up to 13 months