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This study propose neoadjuvant chemotherapeutic role by erlotinib.
It is widely accepted that patients with locally advanced non-small cell lung cancer would have better outcome with neoadjuvant therapy followed by surgery than surgery alone. However what should be the standard treatment option is still unclear.
Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase and its anti-neoplastic effect is approved especially women, patients with adenocarcinoma, non-smoker and Asian population. Moreover if the malignant tissue has EGFR mutation, its efficacy is known to be enhanced.
So we expect that in those population, patients with locally advanced, N2 positive, erlotinib would be more beneficial than conventional cytotoxic chemotherapy in safety and convenience as neoadjuvant therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib 150mg per day for 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic down-staging | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | 36 months | |
| Toxicity | 36 months | |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 36 months |
| Overall survival | 36 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |