Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation
Interventions
DRUGstandard chemotherapy medicine combined with Chinese herbs
DRUGstandard chemotherapy medicine
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age \> 18 ages * Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2. * White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L * ALT, AST, normal or less than 2 times, bilirubin is normal * Serum level in the normal range;Thr ecg is normal * Expected survival time≥ 3 months or more; * Agreed to the treatment combined traditional Chinese medicine with western medicine
Exclusion criteria
* Engaged in other clinical subjects * Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail * Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor * Severe damage of heart, liver and kidney (cardiac function grade 3 \ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit) * Mental illness, Refused to partner; Cannot obtain informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rate | 36months |
| progression-free survival rate | 36months |
Other
| Measure | Time frame |
|---|---|
| KPS scores | 36months |
| nutritional evaluation scores | 36months |
| BMS(Bone marrow suppression) scores | 36months |
| Gastrointestinal reactions scores | 36months |
| Quality of Life Questionnaire (EORTC QLQ C30)scores | 36months |
| AST value | 36months |
| ALT value | 36months |
| creatinine value | 36months |
| hair loss level scores | 36months |
| RECIST(Response Evaluation Criteria In Solid Tumors) | 36months |
Countries
China
Contacts
Primary ContactBao-guo Sun, doctor
Backup ContactXin Zhou, master
Outcome results
None listed