This Phase II study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for patients with local advanced non-small cell lung cancer.
This Phase II study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for local advanced non-small cell lung cancer patients. Patients were treated with hypo-RT (30Gy in 6 fractions) followed by hypo-boost (30Gy in 6 fractions) combined with concurrent weekly chemotherapy (docetaxel 25 mg/m2 and cisplatin 25 mg/m2). Consolidation immunotherapy were recommended for those without disease progression or persistent grade2+ toxicities following radiotherapy. 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. 5.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
The radiotherapy is delivered using simultaneous integrated boost (SIB)-intensity-modulated radiotherapy (IMRT). The dose of 30Gy with a fraction dose of 5Gy was delivered to PTV-GTV as the hypo-RT course. Patients were eligible to receive the hypo-boost when there was no disease progression and no persistent ≥G2 treatment-related toxicities. For patients with persistent ≥G2 toxicities, a re-evaluation was planned every 2 weeks to determine whether they were qualified to receive the hypoboost. All eligible patients underwent a repeat 4DCT simulation scan to reformulate the adaptive radiation therapy plan. The adaptive plan of the hypo-boost was delivered to the residual tumor (PTV-GTV-residual) at a dose of 30Gy in 6 fractions (5 Gy per fraction).
Patients received a weekly infusion of docetaxel (25 mg/m2) and cisplatin (25 mg/m2) concurrent with hypo-RT and hypo-boost therapy. Intended chemotherapy included 4 cycles throughout the course of treatment.
Sun Yat-sen University
Guangzhou, China
Progression-free survival
Time frame: 2 year
Overall survival
Time frame: 2 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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Patients without disease progression or persistent grade2+ toxicities after thoracic radiotherapy were recommended to receive consolidation immunotherapy