Stereotactic Body Radiation Therapy in Liver Cancer That Cannot be Removed by Surgery or Transplant

Advanced Adult Primary Liver Cancer Clinical Trial

Official title: Downstaging of Hepatocellular Carcinoma by Stereotactic Body Radiotherapy for Non-Resectable and Non-Transplantable Tumors: Phase 2 Study

Status Withdrawn

Clinical Trial Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue in patients with liver cancer. Giving stereotactic body radiation therapy may also increase patient eligibility for liver transplant.PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with liver cancer that cannot be removed by surgery or transplant.

Clinical Trial Description

PRIMARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3 months.SECONDARY OBJECTIVES:I. To determine in patients with stage B and C Hepatocellular Carcinoma, if Stereotactic Body Radiotherapy can achieve a downstaging rate of >= 30% at 3 and 6 months.II. To determine the rate of Grade 3 or 4 adverse events associated with SBRT for liver tumors. III. To determine the rate of local progression after SBRT. (Based onRECIST criteria)IV. To determine the number of patients who achieve liver transplantation.OUTLINE:Patients undergo 3 fractions of stereotactic body radiation therapy delivered within 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for 2 years. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Localized Unresectable Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer

• NCT number: NCT01194206
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2010
• Completion date: March 2012