Patients that have had staging studies identifying them as AJCC stage IV with up to five liver metastases will be considered for the study. About 60 patients will take part in this study at UT southwestern, Parkland Health \& Hospital System, and Methodist Richardson Cancer Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7 to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last for approximately 1 day and the follow-up portion of the study will last 5 years.
If the patient has met all the eligibility criteria, they will be registered to the study After successful registration to the study and treatment planning session, patients will receive a single fraction of radiation. The total dose a particular patient receives will depend on the dose cohort they are enrolled into. Each treatment will last about one hour and will be given in a particular position to help guide the beams of radiation toward the cancer area. Although it is not mandatory, it is recommended that patients receive corticosteroid premedication (e.g. Decadron 4-10 m.g. p.o. in a single dose or equivalent) 15-60 minutes prior to each treatment for the intended purpose of modulating immediate acute inflammatory effects and providing anti-emetic support.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Single fraction SBRT
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
The maximum tolerated dose of single fraction stereotactic radiotherapy in patients with hepatic metastases.
The dose of single fraction stereotactic radiotherapy will be escalated without exceeding the maximum tolerated dose in patients with hepatic metastases.
Time frame: 3 years
The dose-limiting toxicity.
Time frame: 3 years
The actual 6 and 12 month local control rates
Time frame: 4 years
An optimal therapeutic window between control and toxicity
Time frame: 3 years
The 3 month tumor response rate
Time frame: 3 month
The survival rate
Time frame: 5 years
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