This clinical trial investigates how well radiation segmentectomy versus stereotactic body radiation therapy works in treating patients with early stage liver cancer. Radiation segmentectomy is a radiation treatment that delivers radioactive particles to the tumor through the bloodstream. Stereotactic body radiation therapy is a non-surgical radiation treatment used to treat tumors by precisely delivering radiation in high-doses from a source outside the body. This trial is being done to determine if there is a difference in how small liver tumors respond between two different types of standard of care treatment, radiation segmentectomy and stereotactic body radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04235660.
PRIMARY OBJECTIVE:
I. To assess feasibility as measured by screen failures and rate of recruitment into a randomized trial comparing radiation segmentectomy (RS) and stereotactic body radiation therapy (SBRT).
SECONDARY OBJECTIVES:
I. To compare the proportion of patients with toxicities (>= grade 4) using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 between RS and SBRT for patients with small (=< 3 cm) solitary hepatocellular carcinoma (HCC).
II. To compare the mean change in hepatobiliary function, as measured 3 months after treatment using a functional hepatobiliary iminodiacetic acid (HIDA) scan, between RS and SBRT for patients with small (=< 3 cm) solitary hepatocellular carcinoma (HCC).
III. To compare the mean change in patient-reported outcomes (PROs) from baseline, at 1, 3 and 6 months, between RS and SBRT, for patients with small (=< 3 cm) solitary hepatocellular carcinoma (HCC), using Functional Assessment of Cancer Therapy General (FACT -G) and COST Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires.
IV. To compare the disease-free survival (DFS) rates of RS and SBRT at 2 years using Modified Response Evaluation Criteria in Solid Tumors (mRECIST) on computed tomography (CT) or magnetic resonance (MR) for patients with small (=< 3 cm) solitary hepatocellular carcinoma (HCC).
V. To compare 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.
VI. To measure the objective response rate (ORR) of radiation segmentectomy (RS) and stereotactic body radiation therapy (SBRT) as measured at 6 months using mRECIST for patients with small (=< 3 cm) solitary hepatocellular carcinoma (HCC) to better allow for an appropriately powered trial evaluating the efficacy of these treatments.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo yttrium Y-90 radiation segmentectomy on a single day.
ARM II: Patients undergo stereotactic body radiation therapy for 3-5 fractions delivered every other day or twice weekly.
After completion of treatment, patients are followed up at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorPaul M Haste
