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BACKGROUND	Traditional Chinese medicine ( TCM ) is considered an important complementary therapy with beneficial effects for cancer patients .
BACKGROUND	Elderly patients with non-small-cell lung cancer ( NSCLC ) are a complex patient group with increasing co-morbidity and shrinking physiological reserve , and may derive substantial benefit from the supportive aspects of TCM .
BACKGROUND	Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer .
BACKGROUND	This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC .
METHODS	This is a double-blind controlled , multi-center , and prospective study with randomly selected participants from elderly NSCLC patients in China .
METHODS	Seventy-six patients who meet the inclusion criteria will be allocated into two groups , which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles .
METHODS	Progression-free survival ( PFS ) is the primary end point , and the secondary end points are overall survival , objective response rate , time-to-progression , and quality of life ( EORTC QLQ-LC43 , and TCM syndrome score ) .
METHODS	Meanwhile , other end points such as toxicity , side effects and safety of the treatments will be assessed .
CONCLUSIONS	Results from this study may provide evidence on the effectiveness , and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC .
BACKGROUND	ClinicalTrials.gov .
BACKGROUND	( Identifier : NCT01780181 ) .

