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State Administration of Traditional Chinese Medicine of Shanghai

18 Years
75 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

State Administration of Traditional Chinese Medicine of Shanghai

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.

Inclusion Criteria:

1. Meet the diagnostic criteria of primary bronchial lung cancer, and pathologically or
cytologically confirmed of NSCLC (squamouscarcinoma, adenocarcinoma, adenosquamous
carcinoma and large cell carcinoma) patients;

2. Age > 18 years old;

3. TCM syndromes are Yin deficiency, Qi deficiency, deficiency of both Qi and Yin,
deficiency of both Spleen and Kidney;

4. Physical status score (ECOG PS) ≤ 2 scores;

5. Stage Ib ~ Ⅲb with complete resection, chemotherapy is performed in 6 weeks after
resection, including tumor size > 2cm of stage Ia;

6. Blood routine: N > 1.5×109/L、PLT > 100×109/L, normal liver function and kidney

7. Voluntarily involved to clinical study and sign informed consent.

Exclusion Criteria:

1. Suffering from other primary malignant tumor in 5 years;

2. Incomplete resection or uncertain to take resection;

3. Serious disease of heart, liver, kidney with severe dysfunction;

4. Pregnancy or breast-feeding women;

5. Mental or cognitive disorders which would influence judgment of QOL in this study;

6. During or had adjuvant chemotherapy;

7. Being participating other drug trials;

8. Allergy to the drug in our study.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

xu ling

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai University of Traditional Chinese Medicine


China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Study ID:

LC 001



Start Date:

November 2011

Completion Date:

December 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms