To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.
Rational: After inductive TKI therapy in NSCLC with sensitizing EGFR mutations, the residual lesion might be the source of subsequent disease progression, defined as acquired resistance to TKI. Two reasons can be used to explain the formation of the residual lesion:1)there is a subgroup of cancer cells that are not sensitive to TKI therapy because of tumor heterogeneity, like de novo T790M mutation; 2)some cancer cells can keep static state during the beginning treatment, and then develops acquired resistance to TKI therapy under the long-term drug pressure and continue to re-proliferation. From this point of view, elimination of residual lesion provides the chance to reduce or slow the possibility of developing resistance to TKI. Objective: To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
40-45 Gy/5-15f
Progression free survival
Time frame: 3 years
Frequency of T790M mutation before treatment detected by ctDNA
Time frame: 1 months
Abundance of T790M mutation before treatment detected by ctDNA
Time frame: 1 months
Frequency of T790M mutation after radiotherapy detected by ctDNA
Time frame: 3 months
Abundance of T790M mutation after radiotherapy detected by ctDNA
Time frame: 3 months
Frequency of T790M mutation after 1 year detected by ctDNA
Time frame: 1 year
Abundance of T790M mutation after 1 year detected by ctDNA
Time frame: 1 year
Rate of CTCAE grade 2 or higher radiation pneumonitis
We will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy.
Time frame: 1 years
To assess the short-term quality of life (QOL)
FACT-E score at the 4 months after docetaxel consolidation therapy
Time frame: 4 months
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