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

Official Title

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

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 tumour 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 tumour and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumour cells.

Trial Description

Primary Outcome:

• Overall survival (OS)

Secondary Outcome:

• TTP
• PFS
• Grade 4 or 5 hepatic adverse events, grade 4 or 5 gastrointestinal AEs, grade 4 thrombocytopenia associated with any bleeding or grade 5 thrombocytopenia. All AEs must be definitely or probably related to protocol treatment and use CTCAE version 4.0
• Health related quality of life assessments measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)
• Quality adjusted survival defined as the weighted sum of different time in different health states added up to a total quality-adjusted survival time using EuroQol (EQ-5D)

PRIMARY OBJECTIVES:

• To determine if stereotactic body radiation therapy (SBRT) improves overall survival in hepatocellular carcinoma (HCC) patients treated with sorafenib (sorafenib tosylate).

SECONDARY OBJECTIVES:

• 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.
• To measure differences in toxicity in HCC patients treated with sorafenib versus SBRT followed by sorafenib.
• To measure vascular thrombosis response post sorafenib versus SBRT followed by sorafenib.
• 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.
• Collection of biospecimens for future correlative studies to investigate differences in potential biomarkers in patients treated with sorafenib versus SBRT followed by sorafenib.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients undergo SBRT every 24-72 hours for a total of 5 fractions over 5 to 15 days. Within 1-5 days post-SBRT, patients receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients are followed weekly during SBRT, monthly during sorafenib tosylate and on the following schedule as a whole from study entry: every 3 months for 3 years, then every 6 months for 2 years and then annually.

View this trial on ClinicalTrials.gov