Y90 Radiation Segmentectomy vs SBRT for HCC

Not Applicable

Terminated

• Conditions: Hepatocellular Carcinoma (HCC)
• Interventions: Radiation: Yttrium-90 Radiation Segmentectomy; Radiation: Stereotactic Body Radiation Therapy

• Registration Number: NCT04235660
• Lead Sponsor: Indiana University

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-22
• Study Start: 2020-07-22
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Results First Submitted: 2023-03-07
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Results First Posted: 2023-10-25
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yttrium-90 Radiation Segmentectomy	Yttrium-90 Radiation Segmentectomy	-
Stereotactic Body Radiation Therapy	Stereotactic Body Radiation Therapy	-

Primary Outcome Measures

Name	Time	Method
Feasibility of Recruitment (Recruitment Rate)	24 months	Feasibility of recruitment will be measured by evaluating the proportion of patients enrolled versus those approached for the study after they have been determined to be a candidate.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Any Toxicities	16 months for the first subject and 4 months for the second	the proportion of patients with any toxicities (≥ grade 4) using CTCAE between RS and SBRT for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC).
Mean Change in Hepatobiliary Function	16 months for the first subject and 4 months for the second	the mean change in hepatobiliary function, as measured 3 months after treatment using a functional HIDA scan, between RS and SBRT for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC).
Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score	6 months	the mean change in patient-reported outcomes from baseline, at 1, 3 and 6 months, between RS and SBRT, for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC), using the Functional Assessment of Cancer Therapy- General (FACT-G). scale goes from 0-108 with a higher score being better.
Mean Change in Comprehensive Score for Financial Toxicity	6 months	the mean change in patient-reported outcomes from baseline, at 1, 3 and 6 months, between RS and SBRT, for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC), using the Comprehensive Score for Financial Toxicity (COST). scale is from 0-44 with higher being bettter
Disease-free Survival (DFS) Rates of RS and SBRT	16 months for the first subject and 4 months for the second	the disease-free survival (DFS) rates of RS and SBRT at 2 years using mRECIST on CT or MR for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC).
Time-to-secondary Treatment (TTST) Between RS and SBRT	16 months for the first subject and 4 months for the second	time-to-secondary treatment (TTST) between RS and SBRT for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC) up to 2 years after initial treatment.
Objective Response Rate	6 months	the objective response rate (ORR) of radiation segmentectomy (RS) and stereotactic body radiation therapy (SBRT) as measured at 6 months using mRECIST (appendix IV) for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC) to better allow for an appropriately powered trial evaluating the efficacy of these treatments.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States