NCT00938457

Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Unspecified Adult Solid Tumor

Interventions

Type	Name	Description
RADIATION	stereotactic radiation therapy	Patients undergo stereotactic body radiation therapy
PROCEDURE	implanted fiducial-based imaging	radiation therapy treatment planning
PROCEDURE	cone-beam computed tomography	radiation therapy treatment planning

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-04-01
• First posted: 2009-07-13
• Last updated: 2016-05-19
• Results posted: 2012-07-09

Locations

1 site across 1 country: United States