• Trials · Apr 2015

    Randomized Controlled Trial

    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.

    • Xiao-Bing Yang, Wan-Yin Wu, Shun-Qin Long, Hong Deng, Zong-Qi Pan, Wen-Feng He, Yu-Shu Zhou, Gui-Ya Liao, Qiu-Ping Li, Shu-Jing Xiao, and Jiao-Zhi Cai.
    • Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. yangxiaobing2002@126.com.
    • Trials. 2015 Apr 10; 16: 146.

    BackgroundPatients 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/DesignThis 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.DiscussionIn 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.Trial RegistrationChinese Clinical Trial Registry ( www.chictr.org ): ChiCTR-IOR-14005679 , registered 17 December 2014.

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