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Traditional Chinese Medicine Treatment as Adjuvant Therapy in Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer: Study Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial 期刊论文

编号：

4407823f-aa9e-46f9-b467-addf9d5375a5
作者：

Jiang, Yi(姜怡)#^[1]Liu, Lingshuang(刘苓霜)*^[1]Shen, Liping^[1];Liu, Jiaxiang(刘嘉湘)^[1]Jiang, Gening^[4];Gu, Aiqin^[5];Li, Hecheng^[6];Li, Qi(李琦)^[2]Li, Hegen(李和根)^[1]Huang, Pinxian(黄品贤)^[3]
语种：

英文
期刊：

CLINICAL LUNG CANCER ISSN：1525-7304 2019 年 20 卷 5 期 (E541 - E547) ; SEP
收录：
关键词：

Adjuvant chemotherapy Chinese herbal medicine Disease-free survival Quality of life Radical surgery
摘要：

Adjuvant chemotherapy (AC) has been proven to yield an approximately 5% improvement in 5-year survival for patients with early-stage non-small-cell lung cancer. With such small gains in survival, the optimal treatment regimen remains to be established. Traditional Chinese medicine (TCM) treatment in combination with AC is frequently used in China. The efficacy and safety of this integrated approach should be scientifically evaluated. We present the rationale and study design of the Combined Adjuvant Chemotherapy and Traditional Chinese Medicine (ACTCM) trial (ChiCTR-IPR-16009062). The ACTCM trial, a prospective multicenter double-blind randomized placebo-controlled study, will recruit 312 patients overall from 5 clinical research centers in China. Within 6 weeks of the thoracic surgery, eligible participants with stages IB-IIIA non-small-cell lung cancer will be randomly assigned in a 1:1 ratio to either the treatment or control group. Patients in the treatment group will receive AC combined with TCM herbal treatment for 4 cycles, then TCM herbal plus injection treatment for 4 cycles. Patients in the control group will receive AC combined with TCM placebo for 4 cycles and then TCM placebo for 4 cycles. Treatment will be discontinued if disease progression or unacceptable toxicity occurs. The primary end point is 2-year disease-free survival. Secondary end points include disease-free survival and quality of life. Other end points are TCM symptoms, performance status, and safety of the regimens. Recruitment started in October 2016 and is ongoing. (C) 2019 Elsevier Inc. All rights reserved.
推荐引用方式
GB/T 7714：

Jiang Yi,Liu Ling-shuang,Shen Li-ping, et al. Traditional Chinese Medicine Treatment as Adjuvant Therapy in Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer: Study Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial [J].CLINICAL LUNG CANCER,2019,20(5):E541-E547.
APA：

Jiang Yi,Liu Ling-shuang,Shen Li-ping,Liu Jia-xiang,&Huang Pin-xian.(2019).Traditional Chinese Medicine Treatment as Adjuvant Therapy in Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer: Study Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial .CLINICAL LUNG CANCER,20(5):E541-E547.
MLA：

Jiang Yi, et al. "Traditional Chinese Medicine Treatment as Adjuvant Therapy in Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer: Study Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial" .CLINICAL LUNG CANCER 20,5(2019):E541-E547.
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