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To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC
In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pemetrexed/cisplatin intercalating gefitinib | Experimental | pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles. pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable |
|
| pemetrexed/cisplatin | Active Comparator | pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed/cisplatin intercalating gefitinib | Drug |
| ||
| pemetrexed/cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| disease progression-free survival | the last patient into group for three years or dead | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | the last patients into group for 5 years or dead | 5 years |
| side-effects | the last patient into group for 3 years or dead |
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Inclusion Criteria:
1.Histological or cytological diagnosis of small-cll lung cancer histology
2.18 years or older
3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
4.Local stage SCLC without distant metastases
5.After 1st-line chemotherapy (EP or IP) at least 4 cycles
6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
7.CR or PR assessment by RECIST(1.0) before randomized
8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hailing Yang, MD | Contact | 00862083062825 | bjrf2009@yahoo.com | |
| Fengnan Wang, MD | Contact | 00862083062825 | wangfengnan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiajia Yu, MD | the ethics committee of the first affiliated hospital of Guangzhou MC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Guangzhou MC | Recruiting | Guangzhou | Guangdong | 510120 | China |
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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 |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Drug |
|
| 3 years |
| overall response rate | the last patient into group for 3 years or dead | 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |