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recruiting too slowly
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | rhTPO(recombinant human thrombopoietin) is given on the second, 4th and 9th day of the chemotherapy cycle in a dosage of 15000U once subcutaneously. |
|
| Control group | Active Comparator | 15000U of rhTPO(recombinant human thrombopoietin) is given subcutaneously 6 to 24 hours within the end of chemotherapy cycle, that is, the 8th day for 3 consecutive days (d9 to d11) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human thrombopoietin | Drug | Recombinant human thrombopoietin injection in 15000U/ml/amp. |
|
| Measure | Description | Time Frame |
|---|---|---|
| minimum and maximum value of platelet count after chemotherapy | 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 | nine weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The duration when patient's platelet count remains below 50×109/L | 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) | nine weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Long Wu, Professor | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |