Clinical trial NCT04235660: Y90 Radiation Segmentectomy vs SBRT for HCC
Official title: Yttrium-90 Radiation Segmentectomy Versus Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Early Stage Hepatocellular Carcinoma (HCC): A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study is a single site, prospective, randomized pilot study to assess the feasibility of recruitment of patients into a trial evaluating the efficacy and tolerability of selective transarterial Y90 radioembolization (radiation segmentectomy) versus stereotactic body radiation therapy (SBRT) for solitary early stage (≤ 3cm) hepatocellular carcinoma (HCC).


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and HIPAA authorization
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years at time of informed consent
* Solitary HCC (≤3 cm) diagnosed by imaging (LI-RADS 4-5) or histology
* Childs-Pugh score ≤ 7
* ECOG performance status 0-1
* Tumor location/characteristics eligible for either SBRT or Y90 therapy as deemed by local tumor board
* Adequate organ function defined as:

  1. serum bilirubin \< 4.0 mg/dL ,
  2. albumin \> 2 g/dL

Exclusion Criteria:

* Any prior locoregional therapy to the target tumor
* Any prior radiation therapy to the liver
* Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:

  i. Has undergone a hysterectomy or bilateral oophorectomy; or ii. Has been naturally amenorrheic for at least 24 consecutive months
* Known severe allergic reaction (anaphylaxis) to iodinated contrast
* Coagulopathy (platelets \< 50 K/mm3 and/or INR \> 2) not correctable by transfusion
* Macrovascular invasion or extrahepatic HCC

Primary outcomes:
measure: Feasibility of Recruitment (Recruitment Rate)
timeFrame: 24 months
Secondary outcomes:
measure: Proportion of Patients With Any Toxicities
timeFrame: 16 months for the first subject and 4 months for the second
measure: Mean Change in Hepatobiliary Function
timeFrame: 16 months for the first subject and 4 months for the second
measure: Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score
timeFrame: 6 months
measure: Mean Change in Comprehensive Score for Financial Toxicity
timeFrame: 6 months
measure: Disease-free Survival (DFS) Rates of RS and SBRT
timeFrame: 16 months for the first subject and 4 months for the second
measure: Time-to-secondary Treatment (TTST) Between RS and SBRT
timeFrame: 16 months for the first subject and 4 months for the second
measure: Objective Response Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References: