This study involves patients treated with cisplatin and etoposide (induction therapy), followed by treatment with a drug called S1 (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The primary endpoint is progression free survival and second endpoints are toxicities, overall survival.
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy, and if maintenance therapy with S1 after standard EP regimen induction therapy could prolong progression free survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles. S1 25 mg/m2 oral, everyday until progression disease
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, China
The progression-free survival in this population of patients
The progression-free survival of the enrolled patients from start the combination treatment with cisplatin, etoposide and S1
Time frame: 2.5 years
Percentage of Participants Experiencing an Adverse Event (AE)
Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
Time frame: 2.5 years
The overall survival in this population of patients.
The overall survival of the enrolled patients from start the combination from start the combination treatment with cisplatin, etoposide and S1
Time frame: 2.5 years
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