title: A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  With the aging of the global population, an increasing number of elderly are diagnosed with advanced non-small cell lung cancer. Although systematic chemotherapy has been one of the primary treatments for advanced non-small cell lung cancer worldwide, the elderly cannot always tolerate standard platinum-based doublet chemotherapy, thus resulting in treatment failure. To reduce toxicity, single-agent chemotherapy is often used to treat the elderly with non-small cell lung cancer; however, this may increase the risk of treatment failure due to an inadequate dose. It has been shown that compound kushen injection in combination with chemotherapy can enhance the efficacy and reduce the toxicity. The aim of this trial is to assess the clinical effectiveness and safety of compound kushen injection in combination with single-agent chemotherapy versus platinum-based doublet chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer.
  
  
  METHODS
  This multicenter study will be an open-label, randomized controlled trial. Three hundred seventy elderly patients with advanced non-small cell lung cancer will be randomly divided into experimental (n = 185) and control groups (n = 185) to receive compound kushen injection in combination with single-agent chemotherapy or standard platinum-based doublet chemotherapy for two cycles. After two cycles, the disease control rate, objective response rate, clinical symptoms, quality of life, Karnofsky Performance Status, and side effects will be assessed. Follow-up evaluations will be performed every 8 weeks to evaluate the progression-free and overall survival.
  
  
  CONCLUSIONS
  Before the trial was designed, compound kushen injection was shown to be effective for lung cancer through basic experiments and clinical trials. This study will determine whether or not the efficacy of compound kushen injection in combination with single-agent chemotherapy is comparable to that of platinum-based doublet chemotherapy, and whether or not the toxicity of compound kushen injection in combination with single-agent chemotherapy is lower than that of platinum-based doublet chemotherapy.
  
  
  BACKGROUND
  ChiCTR-IPR-14005484 (16 November 2014).
authors.affiliation: Oncology Department of Guang'anmen Hospital, Affiliated to China Academy of Chinese Medical Sciences, No. 5, Bei Xian-ge Road, Xi Cheng District, Beijing, 100053, China. wxq791875354@126.com.|Beijing University of Chinese Medicine, No. 11, East Road North 3rd Ring Road, Chao Yang District, Beijing, 100029, China. wxq791875354@126.com.
authors.forename: Xue-Qian
authors.initials: XQ
authors.lastname: Wang
authors.affiliation: Oncology Department of Guang'anmen Hospital, Affiliated to China Academy of Chinese Medical Sciences, No. 5, Bei Xian-ge Road, Xi Cheng District, Beijing, 100053, China. dr.liujie@163.com.
authors.forename: Jie
authors.initials: J
authors.lastname: Liu
authors.affiliation: Oncology Department of Guang'anmen Hospital, Affiliated to China Academy of Chinese Medical Sciences, No. 5, Bei Xian-ge Road, Xi Cheng District, Beijing, 100053, China. linhongsheng1949@sina.com.|Beijing University of Chinese Medicine, No. 11, East Road North 3rd Ring Road, Chao Yang District, Beijing, 100029, China. linhongsheng1949@sina.com.
authors.forename: Hong-Sheng
authors.initials: HS
authors.lastname: Lin
authors.affiliation: Oncology Department of Guang'anmen Hospital, Affiliated to China Academy of Chinese Medical Sciences, No. 5, Bei Xian-ge Road, Xi Cheng District, Beijing, 100053, China. houwei1964@163.com.
authors.forename: Wei
authors.initials: W
authors.lastname: Hou
mesh_terms: D000367:Age Factors; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D002985:Clinical Protocols; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D017567:Karnofsky Performance Status; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage; D016016:Proportional Hazards Models; D011788:Quality of Life; D012107:Research Design; D043823:Taxoids / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D004365:Drugs, Chinese Herbal; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D016190:Carboplatin; C494416:kushen; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine