Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Mayo Clinic9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Metastatic Cancer

Interventions

quality-of-life assessmentPROCEDURE

stereotactic body radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Maximum tolerated dose

Secondary Outcomes

Toxicity profile

Adverse events profile

Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory

Response profile

Physical exam results

Data from ClinicalTrials.gov

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