Cancer Clinical Trial
Official title:
Study of Chinese Medicine Plus Targeted Therapy Maintenance Versus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma: A Randomized Double-blind Controlled Clinical Trial
The investigators performed a randomized, double blind controlled, prospective study method on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy maintenance to prolong the efficacy of long-term survival of advanced pulmonary adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3 years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of targeted maintenance therapy.
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. Epidermal growth factor receptor tyrosine
kinase inhibitors (EGFRTKIs) such as Iressa and Erlotinib have proved effective in first or
second line therapy for advanced pulmonary adenocarcinoma. Targeted therapy maintenance can
be partly extend patient's TTP, but the toxicity and the side effects of targeted therapy
will decrease QOL. Besides, high cost of targeted therapy will cause greater economic
pressure on patients.The investigators' 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 pulmonary adenocarcinoma patients with stage Ⅲ～Ⅳ. Advanced pulmonary
adenocarcinoma patients after first-line chemotherapy will choose maintenance therapy
according to the patient's wishes, including targeted therapy maintenance, chemotherapy
maintenance and TCM maintenance therapy. Patients who choose targeted therapy maintenance are
randomized over observational group (TCM granules plus targeted therapy maintenance),and
control group (TCM placebo plus targeted therapy 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: OS (overall
survival); Secondary efficacy assessments are: (1) PFS (progression-free survival); (2)
Objective response rate; (3) QOL (Functional Assessment of Cancer therapy-lung, FACT-L4.0
scales; Lung Cancer Symptom Scale, LCSS); (4) 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 targeted therapy
maintenance has a better efficacy on prolonging progression-free survival time, overall
survival, improving QOL of patients than that of targeted therapy maintenance. Therefore the
study can provide evidences for optimizing and promoting integrated TCM combined with Western
Medicine treatment.
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