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This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population. An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.
evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population.
An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan plus Cisplatin | Experimental | first line: irinotecan 65mg/m2 d1,8. Cisplatin 30mg/m2,d1,8, 21days/cycle×6 cycles Second-line: etoposide alone OR etoposide plus cisplatin, dosage will be same as first line or on investigator's discretion. |
|
| Etoposide plus Cisplatin | Experimental | first line: etoposide 60mg/m2 d1-5 Cisplatin 75mg/m2,d1(recommended), or administer three times with same total daily dose , 21days/cycle×6 cycles Second-line: irinotecan alone or irinotecan plus cisplatin, dosage is same as first line or on investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | 40mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival of first line therapy | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 36 months | |
| Objective Response Rate | 24 months | |
| Number of patients experience adverse events |
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Inclusion Criteria:
Exclusion Criteria:
Uncontrolled tumor metastasis in central nerve system; Uncontrolled hypertension, unstable angina, MI history, or congestive heart-failure, uncontrolled arrhythmia, ischemic vascular disease within the 12 months prior to study treatment; Myocardial ischemia by ECG or valvular heart disease; Grade 3 or above peripheral neuropathy; Active stage of infection by bacteria, fungi or virus; Pregnant or breast feeding woman; History of uncontrolled mental disease.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shun Lu, M.D | Contact | 86-13601813062 | shun_lu@hotmail.com | |
| zhiwei Chen | Contact | 86-13916251926 | drchenzhiwei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shun Lu, M.D | Shanghai Chest hospital of Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of AnHui Medical University | Recruiting | Hefei | Anhui | China |
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| Etoposide | Drug | 5ml:0.1g |
|
|
| Cisplatin | Drug | 6ml:30mg |
|
|
| 36 months |
| Progression free survival of second line therapy | 24 months |
| FuJian Provincial Tumor Hospital | Not yet recruiting | Fuzhou | Fujian | China |
|
| Guangdong General Hospital | Active, not recruiting | Guangzhou | Guangdong | China |
| Cancer Hospital Affiliated To GuangXi Medical University | Recruiting | Nanning | Guangxi | China |
|
| Fourth hospital of hebei medical university | Recruiting | Shijiazhuang | Hebei | China |
|
| The First Affiliated Hospital of HaErBin Medical University | Recruiting | Haerbin | Heilongjiang | China |
|
| HeNan Provincial Tumor Hospital | Recruiting | Zhengzhou | Henan | China |
|
| WuHan Tongji Hospital | Recruiting | Wuhan | Hubei | China |
|
| HuNan Provincial Tumor Hospital | Recruiting | Changsha | Hunan | China |
|
| JiangSu Provincial Tumor Hospital | Recruiting | Nanjing | Jiangsu | China |
|
| The First Affiliated Hospital of NanChang University | Active, not recruiting | Nanchang | Jiangxi | China |
| LiaoNing Provincial Tumor Hospital | Active, not recruiting | Shenyang | Liaoning | China |
| ShanDong Provincial Tumor Hospital | Recruiting | Jinan | Shandong | China |
|
| Linyi cancer hospital | Recruiting | Linyi | Shandong | China |
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| Changhai Hospital of Shanghai | Recruiting | Shanghai | Shanghai Municipality | China |
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| East Hospital Affiliated To Tongji University | Active, not recruiting | Shanghai | Shanghai Municipality | China |
| Shanghai Chest hospital of Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | China |
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| Hangzhou First People's Hospital | Active, not recruiting | Hangzhou | Zhejiang | China |
| The second affiliated hospital of zhejiang university school of medicine | Recruiting | Hangzhou | Zhejiang | China |
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| ZheJiang Provincial Tumor Hospital | Active, not recruiting | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D005047 | Etoposide |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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