Expired Study
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Jacksonville, Florida 32224


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Metastatic liver lesion ≤ 5 cm in dimension - Willing and able to undergo percutaneous placement of localization seeds PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Life expectancy ≥ 12 weeks - Platelet count ≥ 75,000/µL - Hemoglobin ≥ 9 g/dL - ANC ≥ 1,500/mL - Total bilirubin ≤ 1.5 x upper limit of normal (ULN) - AST ≤ 3 x ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to complete questionnaires alone or with assistance - No medical, social, or economic circumstance, that is likely to prevent adherence with the protocol PRIOR CONCURRENT THERAPY: - No prior radiation therapy to the liver - No chemotherapy ≤ 4 weeks prior to registration - Able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks [4 weeks prior to and 4 weeks after registration] surrounding stereotactic radiotherapy


NCT ID:

NCT00567970


Primary Contact:

Principal Investigator
Laura A. Vallow, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Jacksonville, Florida 32224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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