Clinical Study of Chinese Medicine Plus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer
Condition: Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators performed a randomized, prospective study method on observation of
      Traditional Chinese Medicine(TCM) combined with chemotherapy maintenance to prolong the
      efficacy of long-term survival of advanced non small cell lung cancer(NSCLC) patients.The
      investigators plan to involve 100 cases for observation in 3 years (50 cases for chemotherapy
      maintenance, 50 cases for chemotherapy maintenance plus TCM), expecting that integrated TCM
      combined with chemotherapy maintenance has a better efficacy on prolonging progression-free
      survival time, overall survival, improving quality of life(QOL) of patients than that of
      chemotherapy maintenance.
    

Detailed description: 
      Maintenance therapy refers to systemic therapy that may be given for patients with advanced
      NSCLC after 4 to 6 cycles of first-line chemotherapy. However, patients are only candidates
      for maintenance therapy if they have responded to their previous treatment or have stable
      disease and their tumors have not progressed. Pemetrexed, docetaxel and gemcitabine have been
      approved for chemotherapy maintenance in the NCCN Guide. Chemotherapy maintenance can be
      partly extend patient's TTP, but the toxicity and the side effects of chemotherapy will
      decrease the QOL, and even lose the opportunity to receive subsequent therapy. Besides, high
      cost of chemotherapy will cause greater economic pressure on patients. Our preliminary
      studies have shown that traditional Chinese medicine (TCM) can prolong survival time and
      improve QOL, but high-level evidences are needed.

      The investigators perform a multicenter, randomized, double-blind controlled, prospective
      study in advanced non small cell lung cancer patients with stage Ⅲ～Ⅳ.Advanced NSCLC patients
      after first-line chemotherapy will choose maintenance therapy according to the patient's
      wishes, including targeted therapy maintenance, chemotherapy maintenance and maintenance of
      TCM therapy. Patients who choose chemotherapy maintenance are randomized over observational
      group (TCM granules plus chemotherapy maintenance),and control group (TCM placebo plus
      chemotherapy maintenance). The treatment should be continued until evidence of disease
      progression or unacceptable toxicity, and after that regular follow-up will be arranged. The
      primary efficacy assessments are: PFS (progression-free survival）; Secondary efficacy
      assessments are: (1) OS(overall survival); (2) Objective response rate; (3)
      TTP（Time-to-Progression）; (4) QOL (Functional Assessment of Cancer therapy-lung, FACT-L4.0
      scales;Lung Cancer Symptom Scale,LCSS); (5)other efficacy assessments are: 1) TCM symptoms
      changes; 2) Toxicity, side effects and security of the treatments will be assessed at the
      same time.The investigators expect that integrated TCM combined with chemotherapy maintenance
      has a better efficacy on prolonging progression-free survival time, overall survival,
      improving QOL of patients than that of chemotherapy maintenance. Therefore our study can
      provide evidences for optimizing and promoting integrated TCM combined with Western Medicine
      treatment.
    

Intervention name(s): YiQiFang; YangYinFang; YiQiYangYinFang; Gemcitabine®; Pemetrexed®; Docetaxel®; placebo granules
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable.; Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable.; Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable.; "Gemcitabinie®","Gemzar",1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days until progression or unacceptable toxicity develops.; "Pemetrexed®","Alimta",500 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity develops.; "Docetaxel®","Taxotere",75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.; Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable.
Other intervention name(s): Gemzar; Alimta; Taxotere
Intervention MeSH terms: Gemcitabine; Docetaxel; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lung cancer; traditional Chinese medicine; maintenance therapy; chemotherapy