title: Fuzheng Kang'ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Patients with advanced non-small cell lung cancer (NSCLC) harboring mutations of the epidermal growth factor receptor (EGFR) gene respond well to the EGFR tyrosine kinase inhibitor (TKI) gefitinib. Chinese herbal medicine (CHM) has been used as a complementary therapy for cancer for decades in China. CHM was proved to be effective in improving the quality of life (QOL) and reducing the toxicity associated with chemotherapy in patients with NSCLC. The purpose of the present trial is to determine whether CHM (Fuzheng Kang'ai decoction (FZKA), a CHM formula) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone.
  
  
  METHODS
  This is a randomized, placebo-controlled, double-blind trial. This trial is designed to determine if CHM (FZKA) combined with gefitinib results in longer progression-free survival with less toxicity than gefitinib alone. A total of 70 NSCLC patients with EGFR mutations will be randomly assigned to treatment group (gefitinib plus FZKA granules) or control group (gefitinib plus placebo). The primary endpoint is progression-free survival. Secondary endpoints are: (1) overall survival; (2) disease control rate; (3) QOL, measured with the questionnaire of Functional Assessment of Cancer Therapy-lung (FACT-L 4.0) and Lung Cancer Symptom Scale and (4) safety.
  
  
  CONCLUSIONS
  In previous clinical practice, we found that CHM (FZKA) could improve the therapeutic efficacy of gefitinib. This study will provide objective evidence to evaluate the efficiency of CHM combined with gefitinib in NSCLC patients with EGFR mutations, and may provide a novel regimen for patients with NSCLC.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry ( www.chictr.org ): ChiCTR-IOR-14005679 , registered 17 December 2014.
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. yangxiaobing2002@126.com.
authors: Xiao-Bing
authors: XB
authors: Yang
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. wwanyin@126.com.
authors: Wan-Yin
authors: WY
authors: Wu
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. thinkinglong@126.com.
authors: Shun-Qin
authors: SQ
authors: Long
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. denghong163@126.com.
authors: Hong
authors: H
authors: Deng
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. flypzq@126.com.
authors: Zong-Qi
authors: ZQ
authors: Pan
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. hwfzll@126.com.
authors: Wen-Feng
authors: WF
authors: He
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. 20387493@qq.com.
authors: Yu-Shu
authors: YS
authors: Zhou
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. liaoguiya_ya@126.com.
authors: Gui-Ya
authors: GY
authors: Liao
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. liqiupinga@163.com.
authors: Qiu-Ping
authors: QP
authors: Li
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. shujing-020@163.com.
authors: Shu-Jing
authors: SJ
authors: Xiao
authors: Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. Caijiaozhi@163.com.
authors: Jiao-Zhi
authors: JZ
authors: Cai
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000037:antagonists & inhibitors / Q000235:genetics* / Q000378:metabolism; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics / Q000401:mortality / Q000473:pathology; D002681:China; D002985:Clinical Protocols; D004252:DNA Mutational Analysis; D018450:Disease Progression; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000235:genetics* / Q000378:metabolism; D005260:Female; D000077156:Gefitinib; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009154:Mutation; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor; D004365:Drugs, Chinese Herbal; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; C000606530:fuzheng kang'ai; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077156:Gefitinib