COMBINATION OF WEEKLY CHEST RADIOTHERAPY AND ORAL NAVELBINE FOR NSCLC

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。所列机构为中心机构，不一定是研究者机构。这是一项自愿性实验性试验，适用于诊断为非小细胞肺癌的受试者。受试者可能既往接受过针对该疾病的化疗;但是，既往胸部放疗将排除受试者参与研究。尽管并非所有肺癌组织类型都有资格参与本研究，但大多数肺癌（约80%）属于本研究寻求的特定类型。这项研究是为癌症太晚期的受试者设计的，因此不能以完全切除癌症为目标进行手术。处于其疾病的该阶段的受试者传统上连续接受放射治疗或化学治疗或两种治疗。最近，两种治疗方法同时使用，并显示出更好的结果。具体而言，一类称为Alakaloids的化疗药物与放射治疗联合使用，在小型研究中确定，似乎很有希望。诺维本就是这类药物的一部分。这种药物是通过静脉输注，其药丸形式目前正在开发中。通过药丸给药将更容易，并避免先前经历的通过输注到受试者的静脉中经历的副作用。然而，肺癌的最佳治疗方法尚未确定，需要进行额外的研究以找到更好的治疗肺癌的方法。这项研究的一个目的是调查有多少诺维本片剂可以与放射一起使用，并将导致癌症的增强收缩。在这项研究中，辐射将每周给予一天，而不是像更常用的那样每周分为五天。然而，在世界范围内的各种研究中，每周一次胸部照射本身至少与更常用的每日放疗一样好。这项拟议中的研究将使用剂量增加的药物诺维本药丸形式，以找到最高剂量的诺维本是耐受与放射治疗。最初，每例受试者将接受一剂诺维本，剂量高于前一例受试者的剂量。该剂量递增将持续至确定最高耐受剂量。然后，随后入组研究的受试者将接受较低且先前确定耐受良好的诺维本剂量，该剂量将与一种名为顺铂的药物联合使用。顺铂是肺癌的标准药物，将通过输注以低剂量给予受试者静脉。总共15名患者将接受这种药物组合和每周一次的放射治疗。 本研究的总体目的是评价诺维本和顺铂每周一次联合化疗药物治疗，并在一天内给予放疗是否是治疗非小细胞肺癌的有效方法。该试验还将研究这种治疗的耐受性以及这种治疗对参与者的日常生活和活动的影响。

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 is a voluntary experimental trial intended for subjects who have been diagnosed with non-small cell lung cancer. The subject may have received prior chemotherapy treatment for this disease; however, prior radiotherapy to the chest will exclude the subject from participation. Although not all tissue types of lung cancer are eligible to participate in this study, the majority of lung cancers (approximately 80%) are of the particular type sought for this study. The study is designed for subjects whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. Subjects at this stage of their disease traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both methods of treatment concurrently has been employed and indicates somewhat better results. Specifically, a class of chemotherapy agents called Vinca Alakaloids used in combination with radiation therapy appears promising as determined in small studies. The drug Navelbine is part of this class of drugs. This drug is given as an infusion through the veins, its pill form is currently under development. The administration via pill would be easier and avoid previously experienced side effects that were experienced by infusion into the veins of subjects. Nevertheless, the best treatment for lung cancer has not been established yet and additional studies are necessary to find better ways of treating lung cancer have not been established yet and additional studies are necessary to find better ways of treating lung cancer. One goal of this study is to investigate how much of the Navelbine tablet can be given together with radiation and will result in enhanced shrinkage of the cancer. In this study the radiation will be given one day per week, rather than divided over five days per week as is more commonly used. However, in various studies worldwide, once weekly chest irradiation by itself has been found to be at least as good as the more commonly used daily radiotherapy. The proposed study will use increasing doses of the drug Navelbine in pill form to find the highest dose of Navelbine that is tolerated in conjunction with radiation therapy. Initially, each subject will receive one dose of Navelbine, which is higher than the does of the previous subject. This escalation will continue until the highest tolerated dose has been determined. Then, subjects enrolled subsequently into the study will receive a lower, and previously determined to be well-tolerated dose of Navelbine, which will be combined with a drug called Cisplatin. Cisplatin is a standard medicine for lung cancer and will be administered via infusion into the vein of the subject at a low dose. A total of 15 patients will then be treated with this combination of drugs together with once weekly radiation. The overall purpose of this study is to evaluate if the chemotherapy drug combination of Navelbine and Cisplatin administered once weekly with radiation given on one day is an effective therapy for non-small cell lung cnacer. This trial will also investigate how well this treatment is tolerated and what effects this treatment will have on the everyday life and activities of participants.