This Phase II study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locally advanced none-small cell lung cancer patients.
This Phase II study is to determine the efficacy of split-course chemoradiotherapy(CCRT) in locally advanced non-small cell lung cancer. Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy/17 fractions and 15-18 Gy/5-6 fractions administered in the first and second courses, respectively, with about one-month break. The primary endpoint is progression-free survival, which is calculated from the start of RT to the first identification of disease progression or death. 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
99
Patients are irradiation at a palliative dose in the initial course: 51Gy/17f to PTV-GTV. The disease is re-evaluated three weeks after the end of the initial course using CT. The patient without disease progression according to the RECIST criteria and had a recovery of lung function should get the additional boost. In the second course, the tumor is repositioned and scanned. The residual tumor is then treated with the second course of radiotherapy. A dose of 15-18 Gy/5-6f 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: 3 years
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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