NCT01730937

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation therapy to see how well they work compared to sorafenib tosylate alone in treating patients with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send the radiation dose directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine if stereotactic body radiation therapy (SBRT) improves overall survival in hepatocellular carcinoma (HCC) patients treated with sorafenib (sorafenib tosylate). SECONDARY OBJECTIVES: I. To determine the difference in time to progression (TTP) and progression-free survival (PFS) in HCC patients treated with sorafenib compared to SBRT followed by sorafenib. II. To measure differences in toxicity in HCC patients treated with sorafenib versus SBRT followed by sorafenib. III. To measure vascular thrombosis response post sorafenib versus SBRT followed by sorafenib. IV. To measure differences in health related quality of life (QOL) and quality-adjusted survival in HCC patients treated with sorafenib compared to SBRT followed by sorafenib. V. Collection of biospecimens for future correlative studies to investigate differences in potential biomarkers in patients treated with sorafenib versus SBRT followed by sorafenib.

Conditions

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib	By mouth (PO)
RADIATION	stereotactic body radiation therapy	Intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), and proton therapy are allowed.

Timeline

• Start date: 2013-04-01
• Primary completion: 2022-07-01
• Completion: 2025-09-04
• First posted: 2012-11-21
• Last updated: 2026-01-28
• Results posted: 2023-07-03

Locations

51 sites across 5 countries: United States, Australia, Canada, Hong Kong, South Korea