NCT02507765

Stereotactic Body Radiation Therapy and Transarterial Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

A Pilot Trial of Stereotactic Body Radiation Therapy (SBRT) to Induce Tumor Hyperemia in Combination With Transarterial Chemoembolization (TACE) for Unresectable Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies stereotactic body radiation therapy (SBRT) and transarterial chemoembolization (TACE) in treating patients with liver cancer that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumors and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. SBRT may make TACE more beneficial by increasing blood flow to the tumor, which may allow more of the TACE chemotherapy to enter the tumor. Giving SBRT with TACE may work better in treating patients with liver cancer that cannot be removed by surgery.

Detailed description

PRIMARY OBJECTIVES: I. To establish the feasibility of completing SBRT followed by TACE in a 2 day time period. SECONDARY OBJECTIVES: I. To determine acute tumor perfusion changes after SBRT using functional magnetic resonance imaging (MRI) (magnetic resonance \[MR\]-dynamic contrast enhanced \[DCE\]/perfusion weighted imaging \[PWI\], MR-diffusion, blood oxygen level dependent \[BOLD\] sequences). II. To establish safety and tolerability of this regimen. III. To determine overall response rates (using modified Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria), including objective response rate (partial response \[PR\] + complete response \[CR\]) and clinical benefit rate (stable disease \[SD\] + PR + CR) at 1, 3, and 6 months after TACE. IV. To evaluate local control, progression-free survival, and overall survival at 1, 3, 6, 9, and 12 months after a single-dose of SBRT followed by TACE. V. To correlate micro ribonucleic acid (miRNA) biomarkers with response and toxicity. OUTLINE: This is a dose-escalation study of SBRT. Patients undergo SBRT on day 1 and TACE on day 2. After completion of study treatment, patients are followed up at 1-2 weeks and at 1, 3, 6, 9, 12, 18, and 24 months.

Conditions

• Child-Pugh Class A
• Child-Pugh Class B
• Stage IIIA Hepatocellular Carcinoma
• Stage IIIB Hepatocellular Carcinoma
• Stage IIIC Hepatocellular Carcinoma
• Stage IVA Hepatocellular Carcinoma
• Stage IVB Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT
PROCEDURE	Transarterial Chemoembolization	Undergo TACE

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-01-18
• Completion: 2021-01-05
• First posted: 2015-07-24
• Last updated: 2021-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study