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A Phase I Trial of Highly Conformal Radiation Therapy for Patients
with Liver Metastases
Non-lymphoma liver metastases confirmed pathologically or new
radiographic liver lesions most consistent with metastases in a
patient with known pathologically proven non-lymphoma cancer and
a previously negative contrast CT, MRI or PET/CT of the liver; <=
5 liver lesions measurable on a contrast-enhanced liver CT, MRI
or PET/CT performed within 30 days prior to study entry; Liver
metastases measuring <= 6 cm; All intrahepatic disease must
be encompassed within the radiation fields according to protocol
criteria; Patient is uneligible if deemed medically unfit for surgery
or surgically unresectable; Zubrod Performance Scale = 0-1. Patient
must be > 18 years of age; Adequate bone marrow function, defined
as follows: Absolute neutrophil count (ANC) > 1,800 cells/mm3
based upon CBC/differential obtained within 2 weeks prior to registration
on study; Platelets > 100,000 cells/mm3 based upon CBC/differential
obtained within 2 weeks prior to registration on study; Hemoglobin > 8.0
g/dl based upon CBC/differential obtained within 2 weeks prior
to registration on study (Note: The use of transfusion or other
intervention to achieve Hgb > 8.0 g/dl is acceptable); Previous
liver resection or ablative therapy is permitted; Chemotherapy
must be completed at least 4 weeks prior to radiation; Women of
childbearing potential and male participants must practice adequate
contraception; Patient must sign study specific informed consent
prior to study entry; Pretreatment evaluations required for eligibility
include a complete history and general physical examination; For
women of childbearing potential, a serum or urine pregnancy test
must be performed within 72 hours prior to registration; INR, total
bilirubin, albumin, alkaline phosphatase, ALT, AST within 2 weeks
prior to study entry.
All patients will receive 10 fractions Monday throughFriday for
2 weeks at the following levels; Dose escalation by 0.5 Gy to maximum
of 50 Gy, as follows:
Dose Level I: 3.5 Gy dose per fraction; 35 Gy total dose
Dose Level 2†: 4.0 Gy dose per fraction; 40 Gy total dose
Dose Level 3: 4.5 Gy dose per fraction; 45 Gy total dose
Dose Level 4: 5.0 Gy dose per fraction; 50 Gy total dose
†Protocol treatment begins at Level II
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