Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung: Parallel Control and Single Center
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tumor ORR and Number of Adverse Events
研究概览
简要总结
Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.
详细描述
Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore, this program is applied to neoadjuvant therapy, may obtain better tumor pathological remission rate, improve the operation resection rate, thus improve the prognosis.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Histological or cytological diagnosis of lung squamous cell carcinoma of stage IIB and IIIA.
- •2.18 years or older 3.ECOG Performance Status no more than 2; 4.Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI; 5.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5 x 10E9/L, platelets 100 x 10E9/L; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases; 8.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).
排除标准
- •Any systemic anticancer treatment for NSCLC
- •Local radiotherapy for NSCLC.
- •In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.
- •Any instability in systemic disease, including: active infection, absence of control hypertension, unstable angina, begins in the last 3 months of angina pectoris, congestive heart failure
- •HIV infection;
- •Allergic to paclitaxel or Platinum;
- •mixed with adenocarcinoma, small cell lung cancer;
- •Pregnant or lactating women;
- •Other researchers believe that does not fit into the group
研究组 & 干预措施
nanoparticle albumin-bound paclitaxel
Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung
干预措施: nanoparticle albumin-bound paclitaxel/carboplatin (Drug)
结局指标
主要结局
Tumor ORR and Number of Adverse Events
时间窗: From date of randomization until the date of progression, assessed up to 2 months
次要结局
- PFS(From date of surgery until the date of first documented progression, assessed up to 30 months)
研究者
Jianxing He
The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University