Extensive Stage Sclc Patients Who Were Benefit From First-line Treatment Accept Temozolomide Maintain Therapeutic

Study Overview
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Brief Summary
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This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive stage SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the first line treatment.

Detailed Description
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According to the etoposide combined Los platinum (EL) plan administration, every cycle was 21 days, a total of four cycle. The patients who was clinical benefit directly from EL scheme in the first line treatment accept temozolomide maintenance therapy, 150mg / m2, oral D1-5. A period of 28 days, regular follow-up and evaluation of effectiveness, safety and quality of life.

Official Title
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Lobaplatin Combined With Etoposide for First-line Treatment in Extensive Stage Sclc Then Benefit Patients Follow up Temozolomide Maintain Therapeutic

Conditions
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Extensive Stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 to 70 years old, men and women are not limited; confirmed by histopathological examination SCLC; clinical stage for patients with extensive stage (except for the case of pleural effusion) patients has no drug treatment history the implementation of palliative radiotherapy for metastatic lesions, surgical treatment, after the end of treatment over 14 days. there can be measured lesions (non radiation exposure site) of patients (RECIST) evaluation; physical condition score ECOG PS:0-1 more than expected survival time over 3 months Exclusion Criteria: the previous platinum compounds have a history of allergies; active ulcer patients; Patients with primary lung lesions were treated with radiotherapy; chest X-ray showed clear interstitial pneumonia or patients with pulmonary fibrosis; the need for treatment of brain metastases in the active phase there are more serious tumor invasion, superior vena cava syndrome, or in the middle volume of malignant pleural effusion, abdominal effusion or pericardial effusion, not yet control; there is a serious infection, ADH abnormal secretion syndrome, poor control of diabetes,the need for the treatment of patients with severe complications such as vena cava syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: temozolomide maintain therapeutic<br>Lobaplatin combined with etoposide for first-line treatment of extensive stage small cell lung cancer,then clinical benefit patients for temozolomide maintain therapeutic.This study have only one arm which temozolomide maintain at dose of 150mg/m2 D1-5 Q4W. | Drug: temozolomide<br>* temozolomide maintain therapeutic<br>* Other names: Temozolomide Capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival in the first line of chemotherapy | The first day of treatment to the date that disease progression is reported | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | The first day of treatment to death or last survival confirm date | 3 years | 
| Tumor Response Rate (RR) | The ratio between the number of responders and number of patients assessable for tumor response. | 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 |