Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day).
Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week.
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGResponse rate
Time frame: week 3-4
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.
Toxicity of the treatment will be evaluated according to the common toxicity criteria for adverse events version 3.0 (CTCAE v3.0).
Time frame: year 0- year 2
Progression-free survival
Progression-free survival (PFS) will be calculated from the date of treatment initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.
Time frame: year 0- year 2
Overall survival
Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Time frame: year 0- year 2
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