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Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine. Etoposide and cisplatin chemotherapy is the first-line treatment for small-cell lung cancer. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of apatinib as the maintenance therapy for extensive stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and apatinib 250mg/d , repeated every 21 days, a total of 6 cycles, and then continue to take apatinib 250mg/d until progressive Disease(PD). |
|
| Arm B | Placebo Comparator | Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and placebo, repeated every 21 days, a total of 6 cycles, and then continue to take placebo until PD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib;etoposide and cisplatin | Drug |
| ||
| placebo;etoposide and cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The first day of treatment to the date that disease progression is reported. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The first day of treatment to death or last survival confirm date. | 5 years |
| Tumor response rate | The ratio between the number of responders and number of patients assessable for tumor response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Dong, PH.D. | Contact | 86-23-68757151 | dongwang64@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Dong, PH.D. | Daping Hospital, Third Military Medical University, Chongqing,China | Principal Investigator |
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| Drug |
|
| 3 months |
| Treatment-related adverse events | Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0. | the first date of treatment to 30 days after the last dose of study drug,assessed up to 6 months |
| Performance Status | Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO). | the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months |
| 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 |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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