Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients
Condition: Non-small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators performed a multi-center, randomized, controlled, double-blind, prospective
      study on evaluating effect of chemotherapy combined with or without integrated TCM on quality
      of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators
      plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting
      that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with
      chemotherapy compared to that by chemotherapy alone.
    

Detailed description: 
      At present the high rate of recurrence and metastasis of postoperative non-small cell lung
      cancer (NSCLC) patients is one of the leading causes resulting in failure of treating lung
      cancer. More than 35% of postoperative lung cancer patients with stage I died in 5 years due
      to recurrence or metastasis; the 5-year survival rates of stage II, IIIa, IIIb were 31%,
      17.9% and 11.7% respectively. The survival rate was improved by 5% with adjuvant chemotherapy
      after resection, so regimen consist of platinum-based two chemical medicines are commended as
      the adjuvant chemotherapy for treating postoperative NSCLC patients, but the toxicity and
      side effects of chemotherapy can decrease quality of life (QOL) of patients. Literature and
      our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong
      survival and improve QOL, but high-level evidences are needed.

      The investigators perform a randomized, double-blind study in NSCLC patients after complete
      resection with stage I-III. Patients are randomized over observational group (TCM granules
      plus chemotherapy), and control group (TCM placebo plus chemotherapy). The investigators will
      observe 4 treatment periods, after that the observational group will be treated for another 4
      months with integrated TCM combined with western medicine treatment (oral TCM medicines plus
      TCM intravenous injections), and there is no intervene measures in control group. Regular
      follow-up will be arranged. The primary efficacy assessments are: QOL (QLQ-C30 scales);
      Secondary efficacy assessments are: (1) 2-year disease-free survival rate; (2) disease-free
      survival; other efficacy assessments are: (1) TCM symptoms changes; (2) tumor markers (CEA,
      CA-125 and CYFRA21-1) and so on. Toxicity, side effects and security of the treatments will
      be assessed at the same time. The investigators expect that integrated TCM combined with
      Western medicine treatment has a better efficacy on improving QOL of patients, prolonging
      disease-free survival time than that of chemotherapy treatment. Therefore our study can
      provide evidences for optimizing and promoting integrated TCM combined with Western Medicine
      treatment.
    

Intervention name(s): TCM; placebo
Intervention type(s): Drug; Drug
Intervention description(s): three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.; three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe，with the same color, smell ，taste weight and package
Other intervention name(s): Prescriptions from Professor Liu Jiaxiang
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment