A Phase I/II Trial of Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT for Inoperable,Locally Advanced Esophageal Carcinoma
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progress free survival
研究概览
简要总结
This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients.
详细描述
Esophageal carcinoma is the sixth leading cause of cancer-related mortality from cancer with 407000 deaths and the eighth most common cancer worldwide. Concurrent chemoradiotherapy remains the mainstay of treatment for locally advanced esophageal cancer. Paclitaxel combined with radiotherapy was high efficiency and achieved encouraging results. Compared with paclitaxel, nab-paclitaxel has a low toxicity, low allergy and the tolerance is better than paclitaxel. According to the pre-clinical results, investigators designed a prospective study, which is combined nab-paclitaxel and cisplatin with concurrent chemoradiotherapy for the patients with locally advanced esophageal cancer, and evaluated the tolerability and efficacy. we design enrolled 30 patients, the end point included toxicity, progression-free survival and overall survival.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a（AJCC 2002)
- •ECOG performance status scale 0-1
- •at least 1 measurable target lesions
- •white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level < 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and
- •normal cardiac function with no severe heart disease.
排除标准
- •history of esophagectomy
- •pregnancy or breast feeding
- •past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
- •concomitant treatment with other anticancer drugs.
研究组 & 干预措施
nab-paclitaxel group
Weekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT
干预措施: nab-paclitaxel group (Drug)
结局指标
主要结局
Progress free survival
时间窗: 3 years
次要结局
- Overall survival(3 years)
- CTCAE 4.0 toxicity(6 months)