Overview
Extensive Stage Sclc Patients Who Were Benefit From First-line Treatment Accept Temozolomide Maintain Therapeutic
Status:
Unknown status
Unknown status
Trial end date:
2018-12-01
2018-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Yunpeng LiuTreatments:
Benzocaine
Dacarbazine
Temozolomide
Criteria
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