Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
To assess the efficacy and safety of administration of rhTPO at different time in the treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung cancer (NSCLC)
Detailed description
This is a randomized, controlled, open-labeled, multicenter clinical trial. The subjects are patients with NSCLC who are going to receive GC/GP regimen chemotherapy. Vadhan-Raj et al conducted a study in which they administered rhTPO in various ways to patients with sarcoma receiving platinum-containing chemotherapy. The results demonstrated that timing of administration of rhTPO can be adjusted according to the occurrence time of nadir platelet values induced by chemotherapy. The timing of administration of rhTPO in this study was determined based on the above proofs.
Interventions
Recombinant human thrombopoietin injection in 15000U/ml/amp.
Sponsors
Chinese Society of Lung Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients at the age of 18 to 75 years old 2. Histologically or cytologically diagnosed NSCLC cases 3. Thrombocytopenia occurred in the selected chemotherapy cycle confirmed by double test results with platelet count lower than 75×109/L 4. Fit for chemotherapy (WBC ≥ 4.0×109/L；neutrophil count\> 1.5×109/L；PLT ≥ 80×109/L；ALT ≤ 3 times the upper limit of normal range；AST ≤ 3 times the upper limit of normal range；TBil ≤ twice the upper limit of normal range；ECOG PS ≤ 2；without severe cardiopulmonary defects) 5. Expected lifespan over 12 weeks 6. With understanding ability and voluntarily sign informed consent form 7. Be able to comply with the study and follow-up process
Exclusion criteria
1. With any unstable systemic diseases including active infection, uncontrolled hypertension, liver diseases, renal diseases or metabolic diseases 2. With uncontrolled brain metastasis symptoms (patients whose brain metastasis controlled over 4 weeks without hormone therapy can still be enrolled) 3. With heart cerebrovascular diseases, congestive heart failure with NYHA above II degree, with unstable angina pectoris, with acute myocardial infarction or cerebral infarction within 6 months 4. Breast-feeding or pregnant women 5. Platelet count over 300×109/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| minimum and maximum value of platelet count after chemotherapy | nine weeks | To evaluate the minimum and maximum value of platelet count after chemotherapy and the value of platelet count and their D-values comparing with the baseline values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration when patient's platelet count remains below 50×109/L | nine weeks | The duration when patient's platelet count remains below 50×109/L, the time (in day) when patient's platelet count increases over 75×109/L and 100×109/L, the amount of platelet infused (number of units of apheresis platelet should be transformed into number of units of platelet concentrate) |
Countries
China
Outcome results
None listed