Extensive Stage Small Cell Lung Cancer Clinical Trial
Official title:
Lobaplatin Combined With Etoposide for First-line Treatment in Extensive Stage Sclc Then Benefit Patients Follow up Temozolomide Maintain Therapeutic
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. aged 18 to 70 years old, men and women are not limited; 2. confirmed by histopathological examination SCLC; 3. clinical stage for patients with extensive stage (except for the case of pleural effusion) 4. patients has no drug treatment history 5. the implementation of palliative radiotherapy for metastatic lesions, surgical treatment, after the end of treatment over 14 days. 6. there can be measured lesions (non radiation exposure site) of patients (RECIST) evaluation; 7. physical condition score ECOG PS:0-1 8. more than expected survival time over 3 months Exclusion Criteria: 1. the previous platinum compounds have a history of allergies; 2. active ulcer patients; 3. Patients with primary lung lesions were treated with radiotherapy; 4. chest X-ray showed clear interstitial pneumonia or patients with pulmonary fibrosis; 5. the need for treatment of brain metastases in the active phase 6. 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; 7. 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of China Medical University | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Yunpeng Liu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival in the first line of chemotherapy | The first day of treatment to the date that disease progression is reported | 6 months | No |
Secondary | Overall Survival (OS) | The first day of treatment to death or last survival confirm date | 3 years | No |
Secondary | Tumor Response Rate (RR) | The ratio between the number of responders and number of patients assessable for tumor response. | 3 months | No |
Secondary | 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 | No |
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