Clinical trial NCT02972320: Extensive Stage Sclc Patients Who Were Benefit From First-line Treatment Accept Temozolomide Maintain Therapeutic
Official title: Lobaplatin Combined With Etoposide for First-line Treatment in Extensive Stage Sclc Then Benefit Patients Follow up Temozolomide Maintain Therapeutic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extensive Stage Small Cell Lung Cancer
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression-Free Survival in the first line of chemotherapy
timeFrame: 6 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 years
measure: Tumor Response Rate (RR)
timeFrame: 3 months
measure: Treatment-related adverse events
timeFrame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
References: