A Phase II Trial of Neoadjuvant Chemotherapy With Nanoparticle Albumin-bound Paclitaxel and Fluorouracil Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell carcinoma.
详细描述
In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of nanoparticle albumin-bound paclitaxel plus 5-fluorouracil as perioperative therapy for patients with resectable esophageal carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
- •Locally advanced disease that is technically operable with curative intent (R0)
- •T3, N0 OR T1-3, N+ OR T4, Nx
- •No T1-2, N0
- •No inoperable T4 (unequivocal organ involvement)
- •No distant metastasis, including M1a lymph node status
- •Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
- •No carcinoma of the cervical esophagus
- •Obstructive tumors allowed
排除标准
- •Not suitable to surgery
- •cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
- •early Esophageal Carcinoma(Stage I)
- •complete esophageal obstruction，Esophageal perforation or hematemesis
- •other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
- •pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
- •History of serious allergic or castor oil allergy
- •Patients who are not suitable to participate in the trial according to researchers
研究组 & 干预措施
nanoparticle albumin-bound paclitaxel
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
干预措施: nanoparticle albumin-bound paclitaxel (Drug)
结局指标
主要结局
response rate
时间窗: From date of treatment until the date of progression, assessed up to 2 months
pathological response rate and clinical response rate
次要结局
- Overall survival(Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months)
- Progression-free survival(Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months)
- Adverse events(During the chemotherapy,an expected average of 3 weeks)
研究者
Qiong Zhao
Chief of Department of Thoracic Oncology
Zhejiang University