The primary objective is to assess the safety and efficacy of hypofractionated radiotherapy followed by hypo-boost combined with concurrent weekly chemotherapy in unresectable LA-NSCLC patients.
Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, concurrent with split-course thoracic radiotherapy of 40 Gy/10 fractions and 28 Gy/7 fractions administered in the first and second courses, respectively, with one-month break. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor.
Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
Hui Liu
Guangzhou, Guangdong, China
progression-free survival
Time frame: 3 years
overall survival
Time frame: 3 years
response rate
Time frame: 2 months
rate of grade 3-4 radiation esophagitis
Time frame: 1 year
rate of grade 3-4 radiation pneumonitis
Time frame: 1 year
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