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

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Yttrium-90 Radiation Segmentectomy

Stereotactic Body Radiation Therapy

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Yttrium-90 Radiation Segmentectomy

Stereotactic Body Radiation Therapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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).

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.

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

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).

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.

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.

Full Information

NCT ID

NCT04235660

First Posted

January 15, 2020

Last Updated

October 23, 2023

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT04235660

Brief Title

Y90 Radiation Segmentectomy vs SBRT for HCC

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

unable to recruit. terminated due to futility

Study Start Date

July 22, 2020 (Actual)

Primary Completion Date

March 8, 2022 (Actual)

Study Completion Date

March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma (HCC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Radiologist assessing response will be blinded to the treatment type

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Yttrium-90 Radiation Segmentectomy

Arm Type

Active Comparator

Arm Title

Stereotactic Body Radiation Therapy

Arm Type

Active Comparator

Intervention Type

Radiation

Intervention Name(s)

Yttrium-90 Radiation Segmentectomy

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of Recruitment (Recruitment Rate)

Description

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.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Proportion of Patients With Any Toxicities

Description

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).

Time Frame

16 months for the first subject and 4 months for the second

Title

Mean Change in Hepatobiliary Function

Description

Time Frame

16 months for the first subject and 4 months for the second

Title

Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score

Description

Time Frame

6 months

Title

Mean Change in Comprehensive Score for Financial Toxicity

Description

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

Time Frame

6 months

Title

Disease-free Survival (DFS) Rates of RS and SBRT

Description

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 Frame

16 months for the first subject and 4 months for the second

Title

Time-to-secondary Treatment (TTST) Between RS and SBRT

Description

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.

Time Frame

16 months for the first subject and 4 months for the second

Title

Objective Response Rate

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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

Facility Information:

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

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Y90 Radiation Segmentectomy vs SBRT for HCC

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