The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.
Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.Icotinib is administered orally with a dose 125 mg 3 times daily.
After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine /cisplatin regimen, until untolerable toxicity or disease progression.
Zhejiang cancer hospital
Hangzhou, Zhejiang, China
RECRUITINGObjective response rate
Time frame: 8 weeks
Disease free survival
Time frame: 1 year
The pathological complete response rate after neoadjuvant therapy with icotinib
Time frame: 8 weeks
The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib
Time frame: 8 weeks
The resection rate of patients after neoadjuvant therapy with icotinib
Time frame: 2 months
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