Prolong the Survival of NSCL Patients by a Phytomix

描述(申请人提供)：这项研究的长期目标是开发无毒、抗癌和增强免疫的膳食补充剂，用于治疗癌症和免疫缺陷疾病。具体目标是测试一种特定的“精选蔬菜和草药混合物(SV)”，它由含有已知抗癌和/或免疫增强成分的无毒植物成分组成，是否可以在3期临床试验中延长111B/IV期非小细胞肺癌(NSCLC)患者的生存时间。 非小细胞肺癌在美国每年造成超过15万人死亡，是美国与癌症相关的死亡的主要原因。目前治疗方法的疗效微乎其微。肿瘤对化疗的反应很差，其毒性增加了患者的痛苦。IIIB/IV期NSCLC患者的中位生存期(MST)一直保持在9个月以下。在最近的两个I/II期临床试验中，SV被证明将Ill/IV期和IIIB/IV期NSCLC患者的MST分别提高到15.5个月和33.5个月。SV被证明是无毒的，改善了卡诺夫斯基状态(KPS)，并更好地维持了患者的体重。这些结果令人鼓舞，但必须在大规模随机临床试验中得到证实。 在这项研究中，MST将每三个月评估一次，直到最后一名患者入院后36个月。具有良好表现状态(ECOG表现状态和GT；0或1)的320名IIIB/IV期非小细胞肺癌患者将接受化疗(吉西他滨+顺铂(GC))；在每一层中，随机在他们的日常饮食中添加主动SV或安慰剂SV。如有需要，将同时使用局部治疗、放射治疗和/或手术。这项研究的主要目标是检验SV可能延长IIIB/IV期NSCLC患者生存的假设。评估和比较肿瘤对SV和GC的反应以及各阶层患者的生活质量。考虑到非小细胞肺癌的高发病率和不良预后，对这些患者来说，生存期的适度改善可以转化为数千年的有益增加。

DESCRIPTION (provided by applicant): The broad long-term objective of this study is to develop non-toxic anticancer and immune-enhancing dietary supplements for the treatment of cancer and immune-deficiency diseases. The specific objective is to test whether a specific mixture of "Selected Vegetables and Herbs Mix (SV)", which consists of non-toxic botanicals containing known anti-cancer and/or immune enhancing components, may prolong the survival of stage 111B/IV non-small cell lung cancer (NSCLC) patients in a phase 3 clinical trial. NSCLC causes more than 150,000 annual deaths in the US and is the leading cause for cancer-related death in the nation. The efficacy of current therapies is marginal. Tumors respond poorly to chemotherapy, whose toxicity adds misery to patients. The median survival time (MST) of stage IIIB/IV NSCLC patients has remained under 9 months. In 2 recent phase I/II clinical trials, SV was shown to improve MST of stage Ill/IV and IIIB/IV NSCLC patients to 15.5 month and to 33.5 month respectively. SV was shown to be non-toxic, improved the Karnofsky Performance Status (KPS) and better maintained the patients' body weight. These results are encouraging but must be confirmed in a large scale randomized clinical trial. In this study the MST will be evaluated trimonthly up to 36 months after the entry of the last patient. Three hundred twenty stage IIIB/IV NSCLC patients with good performance status (ECOG Performance Status >0 or 1) will be offered chemotherapy treatment (gemcitabine+cisplatin (GC)); and within each of the strata, randomized to add active SV or placebo SV to their daily diet. Local treatments, radiotherapy and/or surgery, will be used concurrently if indicated. The primary goal of the study is to test the hypothesis that SV may prolong the survival of stage IIIB/IV NSCLC patients. The tumor response to SV and GC and the quality of life of the patients in each stratum will be evaluated and compared. Given the high incidence and poor prognosis of NSCLC, modest improvements in survival can be translated into many thousands of useful added years for these patients.