Metastatic Cancer Clinical Trial
Official title:
A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
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 trial is studying the side effects and best dose of stereotactic
radiation therapy in treating patients with liver metastases.
OBJECTIVES:
- To identify the maximum tolerated dose of stereotactic radiation therapy in patients
with hepatic metastases.
- To determine the toxicity and adverse events profile of this patient population.
- To examine patient response, treatment effect on blood chemistry, and hematology values
and patient quality-of-life in this patient population.
OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3)
and the number of liver lesions present (1-2 vs 3-5 vs > 5).
Patients undergo percutaneous placement of metallic fiducial markers within the liver for
stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic
radiotherapy within 1 week of the marker placement.
Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess
quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study
treatment.
After completion of study treatment, patients are followed for at least 8 weeks.
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