Prolong the Survival of NSCL Patients by a Phytomix

描述（由申请人提供）：本研究的广泛长期目标是开发用于治疗癌症和免疫缺陷疾病的无毒抗癌和免疫增强膳食补充剂。这项研究的目的是在一项第三期临床试验中，测试一种由含有已知抗癌及/或免疫增强成分的无毒植物组成的“特选蔬菜及草药混合物”（SV），是否可以延长111 B/IV期非小细胞肺癌（NSCLC）患者的生存期。 NSCLC在美国每年导致超过150，000例死亡，是美国癌症相关死亡的主要原因。目前的治疗效果是边际。肿瘤对化疗的反应很差，化疗的毒性增加了病人的痛苦。IIIB/IV期NSCLC患者的中位生存时间（MST）保持在9个月以下。在最近的2项I/II期临床试验中，SV显示将III/IV期和IIIB/IV期NSCLC患者的MST分别延长至15.5个月和33.5个月。SV被证明是无毒的，改善了Karnofsky性能状态（KPS），并更好地维持了患者的体重。这些结果是令人鼓舞的，但必须在一个大规模的随机临床试验证实。 在本研究中，将每三个月对MST进行一次评价，直至末例患者入组后36个月。将向320名具有良好体能状态（ECOG体能状态>0或1）的IIIB/IV期NSCLC患者提供化疗治疗（吉西他滨+顺铂（GC））;并且在每个层中，随机将活性SV或安慰剂SV添加到他们的日常饮食中。如有指征，将同时使用局部治疗、放疗和/或手术。本研究的主要目的是检验SV可能延长IIIB/IV期NSCLC患者生存期的假设。将评价和比较各分层患者对SV和GC的肿瘤反应以及生活质量。鉴于NSCLC的高发病率和不良预后，生存期的适度改善可以转化为这些患者的数千年的有益增加。

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.