A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The maximum tolerated dose and the recommended phase II dose
研究概览
简要总结
The goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. Researchers will observe the toxicity response of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m².
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
- •Pathologically confirmed nasopharyngeal carcinoma
- •III-IVa (AJCC8th)
- •age 18-70
- •PS score 0-1
- •normal functions to tolerate chemotherapy and radiotherapy
排除标准
- •The presence of other malignant neoplasms within the preceding five years, with the exception of carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer, is permitted.
- •Symptomatic heart failure, unstable angina, myocardial infarction, active infections requiring systemic therapy, psychiatric disorders, or family and social factors
研究组 & 干预措施
nab-paclitaxel arm
All patients enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively from 180 mg/m² to a maximum of 260 mg/m².
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
The maximum tolerated dose and the recommended phase II dose
时间窗: From start of radiotherapy to 2 weeks after completion of radiotherapy
The maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy.
次要结局
未报告次要终点
研究者
Fang-Yun Xie
professor
Sun Yat-sen University