Y90 Radiation Segmentectomy vs SBRT for HCC

  • STATUS
    Recruiting
  • End date
    May 8, 2024
  • participants needed
    20
  • sponsor
    Indiana University
Updated on 8 September 2021
serum bilirubin

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).

Details
Condition HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Adenocarcinoma, liver cell carcinoma, Liver Cancer, Malignant Adenoma
Treatment stereotactic body radiation therapy, Yttrium-90 Radiation Segmentectomy
Clinical Study IdentifierNCT04235660
SponsorIndiana University
Last Modified on8 September 2021

Eligibility

Yes No Not Sure

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
serum bilirubin < 4.0 mg/dL
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
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