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Stage III non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant double-drug chemotherapy containing platinum plus anlotinib hydrochloride in patients with stage III(N2) non-small-cell lung cancer.
This is a prospective, open-label, multi-institutional, positive medicine control of equal rank comparative study of neoadjuvant double-drug chemotherapy with platinum plus anlotinib hydrochloride in stage III(N2) non-small-cell lung cancer.The main purpose of this study was to compare the difference in N2 downgrade rate of lymph node and resectability rate between the experimental and control groups, to evaluate the efficacy of anlotinib hydrochloride, and to observe and evaluate its objective response rate(ORR),Disease-free Survival (DFS)and overall survival(OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib plus Platinum-based chemotherapy | Experimental |
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| platinum-based chemotherapy | Active Comparator | Platinum-based chemotherapy regimens for neoadjuvant:(1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib hydrochloride | Drug | Anlotinib hydrochloride was given 12mg once daily for two weeks, stop for one week, each 3-week cycle for 2 cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lymph node(N2)downstage rate | Lymph node downstage rate is depended on the image or pathology dignosis after surgery,staging from N2 to N1 / N0. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiexia Zhang, prof. | Contact | +8613903056432 | drzjxcn@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiexia Zhang, prof. | The First Affiliated Hospital of Guangzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 457 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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|
| platinum-based chemotherapy medicine | Drug | (1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles. |
|
| 3 months |
| Resectability rate | Resectability rate was defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy. | Lymph node downstage rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from randomization. |
| Pathological complete response (pCR) rate | Pathologic Complete Response Rate is defined as lack of evidence of viable cancer in the surgical specimen at the time of surgery. | 3 months |
| Disease-free Survival (DFS) | The period after curative treatment [disease eliminated] when no disease can be detected.From date of randomization until the date of first documented progression, whichever came first, assessed up to 40 months. | Every 3 months. |
| Overall Survival (OS) | OS was assessed from randomization to death as a result of any cause. | 3 years |
| adverse events(AEs) | Number of participants with perioperative complications. | 3 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |