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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Changhai Hospital | OTHER |
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The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.
The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma.
In addition, the overall survival and safety index will be collected for analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patient will be administrated with Pemetrexed plus carboplatin combined with gefitinib |
|
| Group B | Experimental | Patient will be administrated with gefitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed plus carboplatin combined with gefitinib | Drug | Pemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | 32 months | |
| Objective response rate (ORR) | 6 months | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiqin Gu, MD | Contact | 13916720655 | Guaiqin11@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Aiqin Gu, MD | Shanghai Chest Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
|
| Gefitinib | Drug | Gefitinib (250mg daily) |
|
|
| 6 months |
| D008175 |
| Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D011799 | Quinazolines |