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/II trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.
OUTLINE: This is a phase I/II, dose-escalation study. Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement. Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Patients undergo stereotactic body radiation therapy
radiation therapy treatment planning
radiation therapy treatment planning
Mayo Clinic
Rochester, Minnesota, United States
Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.
Time frame: 2 months
Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)
LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.
Time frame: At 1 year
Toxicity and Adverse Events Profile (Phase I)
Number of patients with a grade \>= 3 adverse event. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death
Time frame: Up to 2 years
Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)
Time frame: Up to 2 years
Radiographic Response Rate (Phase II)
Time frame: Up to 2 years
Local Control (LC) Cumulative Incidence Rates (Phase II)
Time frame: 3 and 6 months and 1, 2, and 5 years
Median Time to Progression of Treated Tumors (Phase II)
Time frame: Up to 5 years
Refinement of Toxicity and Adverse Events Profile (Phase II)
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Time frame: Up to 2 years
Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)
Time frame: Up to 2 years
Evaluation of Cause of Death (Phase II)
Time frame: Up to 5 years