Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

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.

Inclusion Criteria:

- Signed study specific informed consent form.

- Age ≥ 18.

- Zubrod Performance Status 0-2.

- Biopsy proven primary malignancy.

- Predicted survival of >6 months.

- AJCC Stage IV disease with up to 5 liver metastases as seen on a contrast- enhanced
CT, MRI or PET/CT.

- Ability to spare a critical liver volume as defined by the protocol constraints.

- Tumors must be located outside the Central Liver Zone defined by contouring the portal
vein to its bifurcation + a 3-dimensional 2cm margin

Exclusion Criteria:

- Patients with a history of prior irradiation or other treatment to the liver or
abdomen who after the protocol treatment would have cumulative doses to the liver or
other normal tissues greater than the protocol defined constraints.

- Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy,
radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy,
brachytherapy, and hepatic artery chemotherapy) for the protocol treated lesions
except at progression. Adjuvant systemic therapy before and after the protocol therapy
per section 7.0, and surgery or other ablative therapy is allowed for lesions
appearing after enrollment to this protocol as per section 8.0 is allowed.

- Germ cell or hematologic malignancies.

- History of Crohn's Disease or Ulcerative Colitis.

- Active peptic ulcer disease.

- Underlying hepatic cirrhosis with Child-Pugh class B or C

- A major psychiatric illness which would limit understanding of the proposed protocol
treatment and consent process

- Men and women of reproductive potential may not participate unless they agree to use
an effective contraceptive method.

- Pregnant or lactating women.

- Severe, active co-morbidity

- Abnormal labs