The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation.
Lung cancer is the most common cause of cancer mortality in men and women in the world. LACE meta analysis shows that the 5-year survival rate of post-operation chemotherapy group rose by 5.4%, therefore, adjuvant chemotherapy has been the main treatment after surgery according to National Comprehensive Cancer Network (NCCN) Guideline. But patients have poor compliance due to physical condition after surgery. Compared with adjuvant chemotherapy, neoadjuvant therapy has better patient compliance and tolerance.Targeted therapy, with milder side effect compared with chemotherapy, may be a promising choice to treat NSCLC previously. But to date, there is no enough evidence to support the efficacy and safety of neoadjuvant targeted therapy in patients with EGFR mutation.The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy vs Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable NSCLC patients harboring EGFR mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
590
The patient will be given Navelbine 60 mg/m2, p.o. day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v. day 1 of every cycle.After 2 cycle we will evaluate their clinical response.Then operable patients will have surgery.
The patient will be given Gefitinib 250mg,p.o.,q.d. for 8 weeks.After 8 weeks we evaluate their clinical response.Then operable patients will have surgery.
Dongguan People's Hospital
Dongguan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Maoming Affiliated Hospital of Southern Medical University
Maoming, Guangdong, China
2-year disease free survival
Time frame: 2 years
Objective response rate
Time frame: 1 week before surgery
Pathologic complete response
Time frame: Within 1 month after surgery
Side effects
Time frame: 1 week before surgery
Standard uptake value
Time frame: 1 week before surgery
Tumor reduction rate
Time frame: Within 1 month after surgery
Mediastinal lymph nodes clearance
Time frame: Within 1 month after surgery
Postoperative complications
Time frame: Within 1 month after discharge
R0 resection rate
Time frame: Within 1 month after surgery
Postoperative mortality rate
Time frame: Within 1 month after discharge
5-year overall survival
Time frame: 5 years after surgery
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Shenzhen People's Hospital
Shenzhen, Guangdong, China