Non-small Cell Lung Cancer Clinical Trial
Official title:
State Administration of Traditional Chinese Medicine of Shanghai
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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