Metastatic Cancer
Conditions
Keywords
liver metastases
Brief summary
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
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.
Interventions
PROCEDUREquality-of-life assessment
RADIATIONstereotactic body radiation therapy
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | — |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed