Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
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.
Procedure: quality-of-life assessment
Radiation: stereotactic body radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Toxicity profile [ Designated as safety issue: Yes ]
- Adverse events profile [ Designated as safety issue: Yes ]
- Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory [ Designated as safety issue: No ]
- Response profile [ Designated as safety issue: No ]
- Physical exam results [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567970
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Laura A. Vallow, MD||Mayo Clinic|