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.
Author(s): Yang XB(1), Wu WY(2), Long SQ(3), Deng H(4), Pan ZQ(5), He WF(6), Zhou YS(7),
Liao GY(8), Li QP(9), Xiao SJ(10), Cai JZ(11).
Affiliation(s): Author information:
(1)Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese
Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China.
yangxiaobing2002@126.com. (2)Department of Oncology, Guangdong Provincial
Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou,
Guangdong, 510120, China. wwanyin@126.com. (3)Department of Oncology, Guangdong
Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road,
Guangzhou, Guangdong, 510120, China. thinkinglong@126.com. (4)Department of
Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111
Dade Road, Guangzhou, Guangdong, 510120, China. denghong163@126.com.
(5)Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese
Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. flypzq@126.com.
(6)Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese
Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China. hwfzll@126.com.
(7)Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese
Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120, China.
20387493@qq.com. (8)Department of Oncology, Guangdong Provincial Hospital of
Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou, Guangdong, 510120,
China. liaoguiya_ya@126.com. (9)Department of Oncology, Guangdong Provincial
Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Guangzhou,
Guangdong, 510120, China. liqiupinga@163.com. (10)Department of Oncology,
Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road,
Guangzhou, Guangdong, 510120, China. shujing-020@163.com. (11)Department of
Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111
Dade Road, Guangzhou, Guangdong, 510120, China. Caijiaozhi@163.com.
Publication date & source: 2015, Trials. , 16:146
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/DESIGN: 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.
DISCUSSION: 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.
TRIAL REGISTRATION: Chinese Clinical Trial Registry ( www.chictr.org ):
ChiCTR-IOR-14005679 , registered 17 December 2014.
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