Clinical trial NCT05157451: 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
Overall status: WITHDRAWN
Phase: PHASE2
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
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Oncology
name: Medical Research Foundation, Oregon
name: Oregon Health and Science University
name: Radiation Oncology Institute
name: Radiological Society of North America
First posted: 2021-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Feasibility of enrollment (enrollment rate)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Overall survival
timeFrame: Death, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, lost to follow up, or 13 months post-treatment
measure: Time to progression
timeFrame: 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
measure: Time to intrahepatic progression
timeFrame: Time of radiographic intrahepatic progression, adjuvant systemic therapy or liver directed therapy, transplant, death, or 13 months post-treatment
measure: Rate of liver transplant
timeFrame: Time of liver transplant, death, or 13 months post-treatment
measure: Rate of non-classic radiation induced liver disease
timeFrame: Up to 13 months
measure: Rate of patient reported outcome-Common Terminology Criteria for Adverse Events
timeFrame: Baseline up to 13 months
measure: Change in patient reported quality of life
timeFrame: Baseline to 13 months
measure: Time to next treatment
timeFrame: Time to next liver directed or non-adjuvant systemic therapy, transplant, or death, assessed up to 13 months
Other outcomes:
Locations:
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Nima Nabavizadeh
role: PRINCIPAL_INVESTIGATOR
References: