Cancer Clinical Trial
Official title:
Study of Chinese Medicine Plus Chemotherapy Maintenance Versus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer: A Randomized Double-blind Controlled Clinical Trial
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.
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.
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