HIGH DOSE RADIATION & HEPATIC ARTERIAL FLOXURIDINE IN INTRAHEPATIC MALIGNANCIES

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这项研究将包括18岁以上的患者。它不包括孕妇或囚犯。不会基于性别、种族或人种进行排除。有生育能力的女性患者如果参加本研究，必须采取适当的避孕措施。出于本研究的目的，患者将接受高剂量放疗和化疗治疗不可切除的肝内恶性肿瘤。患者需要放置肝动脉导管以输注化疗药物氟脱氧尿苷（FUdR）。患者将接受两个周期的化疗。FUdR周期将包括以0.2 mg/kg/天的剂量率连续肝动脉输注，从照射前12-24小时开始，持续14天或直至照射完成，以先发生者为准。患者将接受放射治疗的三维治疗计划。放射剂量基于待照射的肝脏体积;治疗的肝脏越少，可以安全给予的剂量越高。总放射剂量将分两部分输送，同时进行FUdR，治疗区组之间休息两周。第一部分约为28.5戈伊。第二部分将完成总治疗剂量。放射治疗将采用每周10 - 11次1.5戈伊分次进行，每天分次间隔至少6小时。所有肝内癌患者都有不可切除的疾病，不能用标准疗法治愈。我们假设，接受这种治疗的患者的结果比不接受治疗或仅接受化疗的类似患者的结果更好。我们计划将患者的结局与历史对照患者进行比较。如果我们的患者的结局足够上级于历史对照组，那么下一步是多机构随机研究，该研究应提供高剂量局灶性肝放射联合肝动脉FUDR在这些患者中的获益（或缺乏获益）的明确证据。

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.