A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

Conditions
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Progression Free Survival

Intervention / Treatment
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* Drug: cisplatin, etoposide
* Drug: cisplatin, etoposide, apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically verified SCLC, extensive stages WHO performance status 0, 1, 2 Age 18 years or older Treatment naive Anticipated survival more than 3 months HB >90g/L, ANC>1.5 x 109/L, Platelets >80 x109 /L No prognancy Signed informed consent Exclusion Criteria: Limited stage disease Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm Uncontrolled hypertension Uncontrolled heart failure Coagulation problem Surgery, trauma, uncontrolled ulcer in 4 weeks. Required by physician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EP chemotherapy<br>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. | Drug: cisplatin, etoposide<br>* 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.<br>|
| Experimental: EP chemotherapy plus apatinib<br>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. | Drug: cisplatin, etoposide, apatinib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | from the date of randomization to disease progression | 24 months |