Cancer
Conditions
Keywords
Chinese Traditional Medicine
Brief summary
The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.
Detailed description
Lung cancer is the most common malignant tumor in the world with about 80%-85% non small cell lung cancer. The investigators perform a multi-center, randomized, controlled, prospective study in patients with advanced NSCLC. Patients are randomized over observational group(Chinese patent drugs plus chemotherapy), and control group (chemotherapy). The investigators will observe 2 cycles and after that regular follow-up will be arranged. The primary end point is: Objective response rate; The secondary end points are: 1. progression-free survival(PFS); 2. overall survival(OS); 3. Time to Progression (TTP); 4. quality of life questionnaire（QOL); 5. other end points are: Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with chemotherapy has a better efficacy on enhancing Objective response rate，prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of chemotherapy.Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
Interventions
DRUGJinFuKang
treated with chemotherapy
DRUGXingZaoRuanJian
treated with chemotherapy
DRUGpemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin
Sponsors
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically or cytologically confirmed of stage Ⅲb-Ⅳ NSCLC 2. Ages Eligible for Study: 18-65 years old; 3. Physical status score (ECOG PS) ≤ 2 scores； 4. Estimated life expectancy of at least 6 months； 5. Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥10g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥80\*109/L, Liver and kidney function is normal; 6. Informed consent from the patient.
Exclusion criteria
1. Patient with other malignant tumor except NSCLC 5 years previous to study entry. 2. Patients who have received targeted drug treatment； 3. Serious problem of heart, liver or kidney with severe dysfunction; 4. Pregnant or child breast feeding women; 5. Mental or cognitive disorders; 6. Participating in other drug trials; 7. Who are allergic to the study drug. 8. Diabetic patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | From date of randomization until the date of first documented progression or date of death from any cause，up to 2 months | The progression disease is assessed based on CT every 2 months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer. |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | up to 2 months |
| Time-to-Progression | up to 2 months |
| Number of participants with treatment-related quality of life as assessed by FACT-L4.0 | 21 days |
Outcome results
None listed