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The purpose of this study is to compare the curative effect of oral S-1 with Pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (NSCLC), and initial to explore a new treatment strategy for advanced non-squamous NSCLC.
S-1 consists of Tegafur,Gimeracil and Oteracil Potassium. Tegafur is metabolize to Gimeracil，and slows down the metabolism of 5-FU in high DPD enzyme expression tumor cell, so that 5-FU could bring the antimetabolic fiction more efficiently. Plenty of studies support that S-1 shows a desirable effect on advanced non-squamous NSCLC, and S-1 is more convenient compare with Pemetrexed. The curative effect of Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC has been proved to be valid. The purpose of our study is to explore whether S-1 could replace Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1 Group | Experimental | Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1) |
|
| Pemetrexed Group | Active Comparator | Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 therapy | Drug | accept S-1(50mg, twice a day, morning and night, if<1.5m2; 75mg, twice a day, morning and night,if >1.5m2 )chemotherapy after finishing first-line therapy(>21 days). |
| Measure | Description | Time Frame |
|---|---|---|
| progress free survival | From date of randomization until the date of first documented progression. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | every subjects needs to be recorded the data of death.From date of randomization until the date of death from any cause. | 3 mouths, 6 mouths, 9 mouths, 1 year |
| objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renhua Guo, MD | Contact | 025-68136360 | rhguo@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongqian Shu, MD | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Renhua Guo, MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19052037 | Result | Shirasaka T. Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol. 2009 Jan;39(1):2-15. doi: 10.1093/jjco/hyn127. Epub 2008 Dec 3. | |
| 20150827 | Result | Kubota K, Sakai H, Yamamoto N, Kunitoh H, Nakagawa K, Takeda K, Ichinose Y, Saijo N, Ariyoshi Y, Fukuoka M. A multi-institution phase I/II trial of triweekly regimen with S-1 plus cisplatin in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2010 May;5(5):702-6. doi: 10.1097/JTO.0b013e3181ce3e22. |
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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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| Pemetrexed therapy | Drug | accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(>21 days). |
|
ORR(objective response rate) is equal to the sum of cases of CR (complete response) and PR (partial response) divided by the total number of evaluable cases.From date of randomization until the date of first documented progression.
| 3 mouths, 6 mouths, 9 mouths, 1 year |
| duration of response | From the date of first documented CR (complete response) or PR (partial response) until the date of first documented progression or recurrence. | 6 weeks, 3 mouths, 18 weeks, 6 mouths, 9 mouths, 1 year |
| 26131116 | Result | Li XN, Qiu D, Pan X, Hou XX. Mutation of the epidermal growth factor receptor gene and its impact on the efficacy of gefitinib in advanced non-small cell lung cance. Int J Clin Exp Med. 2015 Apr 15;8(4):5397-405. eCollection 2015. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |