HIGH DOSE RADIATION & HEPATIC ARTERIAL FLOXURIDINE IN INTRAHEPATIC MALIGNANCIES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This research will include patients over the age of 18. It will not include pregnant women or prisoners. No exclusions will be made based on gender, ethnicity or race. Female patients of childbearing potential must use adequate forms of contraception if they are to take part in this study. For the purposes of this research, patients will undergo high dose radiation and chemotherapy for unresectable intrahepatic malignancies. The patients will need to have a hepatic arterial catheter placed for infusions of the chemotherapy, Fluorodeoxyuridine (FUdR). Patients will receive two cycles of the chemotherapy. A cycle of FUdR will consist of a continuous hepatic arterial infusion at a dose rate of 0.2 mg/kg/day beginning 12-24 hours prior to irradiation and continuing for 14 days or until irradiation is completed, whichever comes first. Patients will undergo 3-dimensional treatment planning for their radiation therapy. The dose of the radiation is based on the volume of the liver to be irradiated; the less liver treated, the higher the dose that can be safely given The total radiation dose will be delivered in two parts, with concurrent FUdR, and a two-week break between the treatment blocks. The first part will consist of approximately 28.5 Gy. The second part will complete the total treatment dose. Radiation therapy will be delivered using ten to eleven 1.5 Gy fractions per week, with fractions separated by at least 6 hours each day. All patients with intrahepatic cancer have unresectable disease, not curable with standard therapies. We hypothesize that the outcome of patients treated with such treatment is better then the outcome of similar patients treated with no therapy or chemotherapy alone. We plan to compare the outcome of our patients to historical control patients. If the outcome of our patients is sufficiently superior to the historical control group, then the next step is a multi-institutional randomized study, which should provide definitive evidence of the benefit (or lack thereof) of high dose focal liver radiation combined with hepatic arterial FUDR in these patients.'