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To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib
Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP chemotherapy | Active Comparator | Standard treatment or active comparator group contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. |
|
| EP chemotherapy plus apatinib | Experimental | Apatinib treatment or experimental group contains standard chemotherapy and apatinib, a VEGF tyrosine kinase inhibitor. It contains a platinum drug, a topoisomerase inhibitor and a VEGF-TKI. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI=apatinib, 500 mg, oral daily after chemotherapy, until disease progression or death or un-tolerated toxicites. Used drugs=cisplatinum and etoposide and apatinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin, etoposide | Drug | The recommended regimen is cisplatin plus etoposide. cisplatin 75 mg/m2 iv on day 1, etoposide 120 mg/m2 iv on day 1-3, 3 weeks a cycle, total for 6 cycles is allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | from the date of randomization to disease progression | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| keke nie, MD | Contact | (86)18561857907 | niekekeqd@163.com | |
| youxin ji, MD, Ph. D | Contact | (86)532-68665078 | ji6677@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhuang Yu, MD, Ph. D | The Affiliated Hospital of Qingdao University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266001 | China |
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| ID | Term |
|---|---|
| C075609 | PE regimen |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| cisplatin, etoposide, apatinib | Drug | Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatin and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI apatinib oral daily after chemotherapy treatment. Apatinib 500mg oral, once a day, until disease progression or death or un-tolerated toxicites. |
|
| 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 |