Y90 Radiation Segmentectomy vs SBRT for HCC

NCT04235660 | Terminated Results DMC FDA Device

• 1 other identifier: IU-2001712954
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of Patients With Any Toxicities

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

• Mean Change in Hepatobiliary Function

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

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

  6 months

• Mean Change in Comprehensive Score for Financial Toxicity

  6 months

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

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

Study Arms (2)

Yttrium-90 Radiation Segmentectomy

ACTIVE COMPARATOR

Radiation: Yttrium-90 Radiation Segmentectomy

Stereotactic Body Radiation Therapy

ACTIVE COMPARATOR

Radiation: Stereotactic Body Radiation Therapy

Interventions

Yttrium-90 Radiation Segmentectomy RADIATION

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.

Yttrium-90 Radiation Segmentectomy

Stereotactic Body Radiation Therapy RADIATION

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.

Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

This study was originally planned as a pilot in hopes of being able to demonstrate feasibility of recruitment into a trail where one arm involved invasive therapy and one non-invasive. Unfortunately, the trial opened very shortly after the beginning of the pandemic in 2020 and overall recruitment/resources for research were hindered. after close to 18 months with little enrollment the funding entity and research team agreed it should just be terminated early for futility.

Results Point of Contact

• Title: Paul Haste
• Organization: Indiana University School of Medicine

phaste@iu.edu

317-944-5005

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiologist assessing response will be blinded to the treatment type
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Radiology & Imaging Sciences

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 22, 2020
• Study Start: July 22, 2020
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2023-10

Locations

US (1)