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This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TS positive cohort & Gem/Cis Tx arm | Experimental | Among TS expression positive patients, some will be randomized to Gem/cis therapy |
|
| TS+ cohort & Pem/Cis arm | Active Comparator | Among patients with TS+, randomised to Pem/cis chemotherapy |
|
| TS negative cohort & Pem/Cis Tx arm | Active Comparator | Among patients with TS-, some will be randomised to Pem/cis Tx arm |
|
| TS negative cohort & Gem/Cis Tx arm | Experimental | Among patients with TS-, some will be randomised to Gem/Cis Tx arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine plus cisplatin | Drug | Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| predictive value of TS expression | To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients | 12 months |
| response rate | Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myung-Ju Ahn, Pf | Contact | 822-3410-3459 | silkahn@skku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Myung-Ju Ahn, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26124486 | Derived | Sun JM, Ahn JS, Jung SH, Sun J, Ha SY, Han J, Park K, Ahn MJ. Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial. J Clin Oncol. 2015 Aug 1;33(22):2450-6. doi: 10.1200/JCO.2014.59.9324. Epub 2015 Jun 29. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| pemetrexed plus cisplatin | Drug | Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks |
|
| pemetrexed plus cisplatin | Drug | pemetrexed 500mg/m2 & cisplatin 70mg/m2 every 3 weeks |
|
| Gemcitabine plus cisplatin | Drug | Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks |
|
| 12 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |