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This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of gefitinib in patients with asymptomatic advanced NSCLC who was benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral gefitinib 250mg once daily until disease progression or unacceptable toxicity. These patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by RECIST criteria after the patient received gefitinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of gefitinib, the patients will receive irradiation of brain metastasis.If the response is stable disease,partial response or complete response,he will be examined by brain MRI every 12 weeks.
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Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | non-randomized open-label uncontrolled phase II trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gefitinib | Drug | gefitinib 250mg qd until disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of asymptomatic brain metastasis turn into symptomatic brain metastasis | 12/2007~12/2010 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety. | 12/2007~12/2010 |
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| Name | Affiliation | Role |
|---|---|---|
| Wu yilong, MD | Director of cancer center of Guangdong PPH | Principal Investigator |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |