Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Procedure: quality-of-life assessment
* Radiation: stereotactic body radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: quality-of-life assessment|nan|
|Radiation: stereotactic body radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity profile |  |  | 
| Adverse events profile |  |  | 
| Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory |  |  | 
| Response profile |  |  | 
| Physical exam results |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver metastases