Y90 Radiation Segmentectomy vs SBRT for HCC

Hepatocellular Carcinoma (HCC) Clinical Trial

— SBRT vs Y90  

Official title:

Yttrium-90 Radiation Segmentectomy Versus Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Early Stage Hepatocellular Carcinoma (HCC): A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04235660
• Other study ID #: IU-2001712954
• Status: Terminated
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: March 8, 2022

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)

Intervention

Radiation:
• Yttrium-90 Radiation Segmentectomy
This therapy arm involves two separate steps, a planning/mapping arteriogram and a therapy delivery. The planning arteriogram will be performed to confirm arterial anatomy is acceptable for RS (=2 segment delivery) and that lung shunting is not too high to preclude treatment with RS. Once confirmed, patients will return for RS (within 45 days of mapping). Dose will be calculated based off the desired treatment volume using pre-treatment cross-sectional imaging. The desired segmental dose will be calculated to be = 200Gy. RS will be performed by one of three separate interventional radiologists with experience in radioembolization. Actual administered activity and location of dose administration will be recorded.
• Stereotactic Body Radiation Therapy
SBRT will be delivered with linear accelerator-based photon beams with either fixed angle non- coplanar fields or dynamic arcs. An internal target volume (ITV) will be generated to account for tumor movement during breathing cycle. Finally, a planning target volume (PTV) will be an expansion of 3- 5mm from the ITV. For Child Pugh A patients, prescription dose will either be 5000cGy in 5 fractions delivered every other day or 4800cGy in 3 fractions delivered twice weekly. For Child Pugh B patients, prescription dose of 4000cGy in 5 fractions delivered every other day. Inverse planning will be used. 95% of the PTV or more will receive at least 100% of the prescription dose. Normal tissue dose constraints for each dose level will be respected with acceptable deviations permitted as outlined in appendix VII. Patients will be seen at least once per week by a clinician to grade toxicities, with on- treatment labs (CBC, CMP, INR) each week.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Recruitment (Recruitment Rate)	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.	24 months
Secondary	Proportion of Patients With Any Toxicities	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).	16 months for the first subject and 4 months for the second
Secondary	Mean Change in Hepatobiliary Function	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).	16 months for the first subject and 4 months for the second
Secondary	Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score	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.	6 months
Secondary	Mean Change in Comprehensive Score for Financial Toxicity	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	6 months
Secondary	Disease-free Survival (DFS) Rates of RS and SBRT	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).	16 months for the first subject and 4 months for the second
Secondary	Time-to-secondary Treatment (TTST) Between RS and SBRT	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.	16 months for the first subject and 4 months for the second
Secondary	Objective Response Rate	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.	6 months