Spots Global Cancer Trial Database for Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

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Trial Identification

Brief Title: Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

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

Study ID: NCT00938457

Conditions

Unspecified Adult Solid Tumor

Interventions

stereotactic radiation therapy

implanted fiducial-based imaging

cone-beam computed tomography

Study Description

Brief 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.