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This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intercalating arm | Experimental | gefitinib, pemetrexed,cisplatin |
|
| chemotherapy alone arm | Active Comparator | Vinorelbine, cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gefitinib, pemetrexed,cisplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | Time from the randomization to recurrence or any cause of death. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from the randomization to death of any cause | 5 year |
| Number of participants with treatment-related adverse events as assessed by CTCAE4.0 | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Byoung Chul Cho, MD | Contact | 82 2 2228 0880 | cbc1971@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
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|
| Vinorelbine, cisplatin | Drug | Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week |
|
|
| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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