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Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low. There is no standard maintenance treatment recommendation for ED-SCLC patients after the first-line therapy.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,so this clinical trial is designed to investigate the efficacy and safety of apatinib combine with etoposide as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib, Etoposide | Experimental | Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib, Etoposide | Drug | Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) . |
|
| 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 | up to 24 months |
| Duration of Response | Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xionghong Cai, Doctor | Contact | 8618036672884 | xionghong_cai@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xionghong Cai, Doctor | Sichuan Cancer Hospital and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sicchuan cancer hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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|
| up to 24 months |
| Tumor response rate | The ratio between the number of responders and number of patients assessable for tumor response. | Time Frame: 3 month |
| Quality of Life (QoL) questionnaire | in cancer patients and survivors with dermatologic conditions. This is a nontherapeutic and nondiagnostic protocol to obtain quality of life assessments from cancer patients and survivors who have dermatologic conditions, whether related to cancer therapies, or directly related to the primary cancer diagnosis. Data will be collected by using one or more dermatology-specific QoL instruments based on the underlying skin condition/s. | up to 24 months |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial 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 |
|---|---|
| C553458 | apatinib |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| 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 |
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