Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Unspecified Adult Solid Tumor Clinical Trial

Official title: A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases

Status Terminated

Clinical Trial Summary

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.

Clinical Trial Description

OUTLINE: This is a phase I/II, dose-escalation study.

Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.

Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study. ;

Study Design

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

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor

• NCT number: NCT00938457
• Study type: Interventional
• Source: Mayo Clinic
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 2009