HIGH DOSE RADIATION & HEPATIC ARTERIAL FLOXURIDINE IN INTRAHEPATIC MALIGNANCIES

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究将包括18岁以上的患者，不包括孕妇或囚犯。不会因性别、种族或种族而被排除在外。有生育潜力的女性患者如果要参加这项研究，必须使用适当的避孕方式。在这项研究中，患者将接受不能切除的肝内恶性肿瘤的高剂量放射和化疗。患者需要放置肝动脉导管来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的一个周期将包括从照射前12-24小时开始以0.2毫克/公斤/天的剂量速率持续肝动脉输注，持续14天或直到照射完成(以先到者为准)。患者将接受放射治疗的三维治疗计划。辐射剂量是基于要照射的肝脏的体积；肝脏治疗越少，在考虑到总辐射剂量的情况下，可以安全提供的剂量就越高，分两部分进行，同时进行FUDR，并在治疗块之间休息两周。第一部分将包括大约28.5Gy射线。第二部分将完成治疗总剂量。放射治疗将使用每周10到11次1.5Gy次，每天至少间隔6小时。所有的肝内癌患者都有不能切除的疾病，不能用标准的治疗方法治愈。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。我们计划将我们患者的结果与历史对照患者进行比较。如果我们的患者的结果足够好于历史对照组，那么下一步是一项多机构的随机研究，这将提供明确的证据，证明高剂量焦点肝辐射结合肝动脉FUDR对这些患者有好处(或没有好处)。“

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.'