Y-90 Versus SBRT for Inoperable HCC

NCT05157451 | Withdrawn Phase 2 DMC FDA Device

• 2 other identifiers: STUDY00022029NCI-2021-11880
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of enrollment (enrollment rate)

  Determine feasibility of trial enrollment for two therapeutic groups.

  Up to 4 years

Secondary Outcomes (8)

• Overall survival

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

• Rate of liver transplant

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

• Rate of non-classic radiation induced liver disease

  Up to 13 months

Study Arms (2)

Arm I (SBRT)

EXPERIMENTAL

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

Other: Quality of Life; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Arm II (Y-90 radioembolization)

EXPERIMENTAL

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

Other: Quality of Life; Other: Questionnaire Administration; Procedure: Yttrium-90 Microsphere Radioembolization

Interventions

Quality of Life OTHER

Ancillary studies

Also known as: QOL, quality of life (QoL), Quality-of-Life

Arm I (SBRT); Arm II (Y-90 radioembolization)

Questionnaire Administration OTHER

Ancillary studies

Arm I (SBRT); Arm II (Y-90 radioembolization)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Arm I (SBRT)

Yttrium-90 Microsphere Radioembolization PROCEDURE

Given via injection

Also known as: Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization

Arm II (Y-90 radioembolization)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• American Society of Clinical Oncology: collaborator
• Medical Research Foundation, Oregon: collaborator
• Oregon Health and Science University: collaborator
• Radiation Oncology Institute: collaborator
• Radiological Society of North America: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Quality of Life; Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nima Nabavizadeh

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: December 1, 2023
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: March 23, 2023

Record last verified: 2023-03