Extensive Stage Small Cell Lung Cancer
Conditions
Brief summary
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
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.
Interventions
DRUGtemozolomide
temozolomide maintain therapeutic
Sponsors
Yunpeng Liu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival in the first line of chemotherapy | 6 months | The first day of treatment to the date that disease progression is reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 3 years | The first day of treatment to death or last survival confirm date |
| Tumor Response Rate (RR) | 3 months | The ratio between the number of responders and number of patients assessable for tumor response. |
| Treatment-related adverse events | the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months | Treatment-related adverse events are assessed by common terminology criteria for adverse events (CTCAE) V4.0. |
Countries
China
Contacts
Primary Contactmingfang zhao, professor
Outcome results
None listed