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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
temozolomide maintain therapeutic
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGProgression-Free Survival in the first line of chemotherapy
The first day of treatment to the date that disease progression is reported
Time frame: 6 months
Overall Survival (OS)
The first day of treatment to death or last survival confirm date
Time frame: 3 years
Tumor Response Rate (RR)
The ratio between the number of responders and number of patients assessable for tumor response.
Time frame: 3 months
Treatment-related adverse events
Treatment-related adverse events are assessed by common terminology criteria for adverse events (CTCAE) V4.0.
Time frame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months
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