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Chemotherapy is one of the main treatments for advanced NSCLC. However, chemotherapy induced thrombocytopenia (CIT) is one of the most important limitations for subsequent chemotherapy of cancer.
Although platelet transfusion is the gold standard to treat severe CIT, its clinical application is limited due to many disadvantages, such as short time for storage, not easy to save, the risk of infection and immunological diseases. What's more, other cytokines including IL-11 and rhTPO, are not so useful in clinical work. It is necessary to explore a new therapeutic method to treat CIT.
Researches show that spleen resection could improve the count of PLT. In this clinical trial, we design chemotherapy plus spleen radiotherapy to the subjects with advanced NSCLC, simultaneously, who underwent grade II or worse CIT. The primary endpoint is the incidence of severe CIT (≧grade III) in subsequent chemotherapy, the second endpoints are recovery time from bone marrow suppression and progression free survival, and the exploring index is the immulogical status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spleen radiation plus spleen radiotherapy | Experimental | Chemotherapy plus spleen radiotherapy Chemotherapy plus spleen radiotherapy are performed, simultaneously, to the subjects with advanced lung cancer who experienced chemotherapy induced thrombocytopenia (≧grade II CIT). The intervention is spleen radiotherapy. |
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| chemotherapy | Other | Chemotherapy is performed to the subjects with advanced lung cancer who experienced chemotherapy induced thrombocytopenia (≧grade II CIT). When severe CIT (≧grade III) occurs, the subjects should receive chemotherapy plus spleen radiotherapy. The intervention is spleen radiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spleen radiotherapy | Radiation | Radiation: spleen radiation In Experimental arm, combine spleen radiation with chemotherapy. In Chemotherapy alone arm, the subjects should also receive spleen radiation once there is a severe CIT (≧grade III) during chemotherapy after radomization. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of severe CIT afer chemotherapy | 18 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time after severe bone marrow suppression | 18 weeks after randomization | |
| Progression free suvival (PFS) | Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Objective response rate (ORR) | Time Frame: 18 weeks after randomization |