As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.
45 Gy for each patient,Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks.
Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGprogression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 3 years
Overall survival
Time frame: From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: the first date of treatment to 3 months after the last dose of study drug
Tumor response rate
Time frame: the ratio between the number of responders and number of patients assessable for tumor response,assessed up to 1 years
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