Overview
Clinical Study of Chemotherapy Combined With Chinese Medicine on Survival Affect of Elderly Patients With Lung Cancer
Status:
Completed
Completed
Trial end date:
2016-09-01
2016-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to observe the efficacy of chemotherapy combined with Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shanghai University of Traditional Chinese MedicineCollaborators:
Fudan University
Shanghai Chest HospitalTreatments:
Docetaxel
Gemcitabine
Vinorelbine
Criteria
Inclusion Criteria:1. Pathologically or cytologically confirmed of stage IIIb-IV NSCLC ;
2. Ages Eligible for Study: ≥65 years old;
3. Physical status score (ECOG PS) ≤ 2 scores;
4. Estimated life expectancy of at least 12 weeks;
5. Participants have no major organ dysfunction and chemotherapy contraindications:
hemoglobin ≥9g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100
*109/L,bilirubin≤1.5ULN,alkaline phosphatase (AP), aspartate transaminase (AST) and
alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is
acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal
range(1.2DLN-1.2ULN),creatinine≤1.5ULN;
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 single-agent chemotherapy treatment;
3. Estimated life expectancy less than 12 weeks;
4. Serious problem of heart, liver or kidney with severe dysfunction;
5. Pregnant or child breast feeding women;
6. Mental or cognitive disorders;
7. Participating in other drug trials;
8. Who are allergic to the study drug.