Y90 Radiation Segmentectomy vs SBRT for HCC (SBRT vs Y90)

Indiana University

Status: Terminated

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Radiation: Yttrium-90 Radiation Segmentectomy; Radiation: Stereotactic Body Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04235660

IU-2001712954

Details and patient eligibility

About

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).

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Yttrium-90 Radiation Segmentectomy

Active Comparator group

Treatment:

Radiation: Yttrium-90 Radiation Segmentectomy

Stereotactic Body Radiation Therapy

Active Comparator group

Treatment:

Radiation: Stereotactic Body Radiation Therapy