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| Name | Class |
|---|---|
| Shenzhen People's Hospital | OTHER |
| Dongguan People's Hospital | OTHER_GOV |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Maoming Affiliated Hospital of Southern Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Navelbine + Carboplatin | Active Comparator | Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with Navelbine + Carboplatin. |
|
| Gefitinib | Experimental | Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with gefitinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Navelbine + Carboplatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year disease free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 1 week before surgery | |
| Pathologic complete response | Within 1 month after surgery | |
| Side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guowei Ma, MD | Contact | 13501546669 | magw@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guowei Ma, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan People's Hospital | Dongguan | Guangdong | 523000 | China |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| D016190 | Carboplatin |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| UNKNOWN |
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| Gefitinib | Drug | 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. |
|
|
| 1 week before surgery |
| Standard uptake value | 1 week before surgery |
| Tumor reduction rate | Within 1 month after surgery |
| Mediastinal lymph nodes clearance | Within 1 month after surgery |
| Postoperative complications | Within 1 month after discharge |
| R0 resection rate | Within 1 month after surgery |
| Postoperative mortality rate | Within 1 month after discharge |
| 5-year overall survival | 5 years after surgery |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
|
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
|
| Maoming Affiliated Hospital of Southern Medical University | Maoming | Guangdong | 525000 | China |
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| Shenzhen People's Hospital | Shenzhen | Guangdong | 518000 | China |
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| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |