Clinical Study of Chemotherapy Combined With Chinese Medicine on Survival Affect of Elderly Patients With Lung Cancer
Condition: Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to observe the efficacy of chemotherapy combined with
      Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer,
      also to evaluate the adverse reaction and the reliability.
    

Detailed description: 
      Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer
      diagnoses and more than 75% of the patients are diagnosed with an advanced stage. ASCO
      guidelines recommended that elderly patients with advanced NSCLC use single-agent
      chemotherapy. Nearly a decade of clinical trials showed that:the median survival time (MST)
      of Vinorelbine is 5-10months,1-year survival rate is 32%;the MST of Gemcitabine is
      6.8-9months,the MST of Taxol is 6.8-10.3months.Research had shown that TCM can prolong
      long-term survival and improve QOL, but high-level evidence is desperately needed to support
      this finding.

      The investigators perform a multi-center, randomized, double-blind controlled, prospective
      study in elderly patients with advanced NSCLC. Patients are randomized over observational
      group (TCM granules plus single-agent chemotherapy), and control group (TCM placebo plus
      single-agent chemotherapy). The investigators will observe 4 cycles and after that regular
      follow-up will be arranged. The primary end point is: PFS (progression-free survival); the
      secondary end points are: (1) OS(overall survival); (2) Objective response rate; (3)
      TTP(Time-to-Progression); (4) QOL (EORTC QLQ-L43, TCM syndrome score); (5) other end points
      are: Toxicity, side effects and security of the treatments will be assessed at the same time.
      The investigators expect that integrated TCM combined with chemotherapy has a better efficacy
      on prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of
      chemotherapy.Therefore our study can provide evidences for optimizing and promoting
      integrated TCM combined with Western Medicine treatment.
    

Intervention name(s): TCM; Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): TCM: In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.The herbal treatment is adapted to the syndromes.; treated with single-agent chemotherapy :DOC、NVB、GEM DOC 60mg/m2 d1 Q3W NVB 30mg/m2 d1，d8 Q3W GEM 1200mg/m2 d1，d8 Q3W
Other intervention name(s): YangYinFang:four packages twice a day; YiQiFang :four packages twice a day; YiQiYangYinFang:four packages twice a day; treated with single-agent chemotherapy :; DOC：Docetaxel; NVB：Vinorelbine; GEM：Gemcitabine
Intervention MeSH terms: Gemcitabine; Docetaxel; Vinorelbine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pathologically or cytologically confirmed of stage IIIb-IV NSCLC； Ages Eligible for Study:
        ≥65 years old; TCM syndromes are deficiency of Yin, deficiency of Qi and deficiency of both
        Qi and Yin.
      
Keywords: lung cancer; traditional Chinese medicine