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.
Status | Completed |
Enrollment | 349 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 ~ ?b 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 function; 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | ShanghaiUTCM | Shanghai | Shanghai |
China | Xuling | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
xuling |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | quality of life(QoL) | every three weeks | No | |
Secondary | two-year disease-free survival rate and disease-free survival | once every three months | No |
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