Taxotere Plus Concurrent Radiotherapy After Induction Chemotherapy for Squamous Cell Carcinoma of the Head and Neck (TAXT-XRT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- MTD of weekly Taxotere
研究概览
简要总结
The purpose of this research study is to develop a new chemo radiotherapy regimen for the treatment of cancer of the head and neck for patients who have received induction chemotherapy; and to determine the highest dose of Taxotere which can be safely given together with radiotherapy.
详细描述
In this investigational research study investigators are attempting to develop a new chemo radiotherapy regimen in which radiotherapy and Taxotere will be combined after having received induction chemotherapy. Taxotere has never been given together with radiotherapy, the highest dose of Taxotere that can be safely used in this setting in unknown. Taxotere will be added to radiotherapy gradually as each subsequent group of 3-5 patients gets a larger dose. Taxotere doses will be increased until certain toxicities occur. This will help investigators determine the best way to combine Taxotere with radiotherapy and to use that knowledge to treat other patients with tumors like yours.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Taxotere
After the screening procedures confirm participation in the research study:
- Taxotere-Administered weekly for 1 hour (6 doses)
- Radiation Therapy (XRT) -5 days a week for 6 weeks
- Exam under anesthesia
- Neck Dissection (if indicated)
干预措施: Taxotere (Drug)
Taxotere
After the screening procedures confirm participation in the research study:
- Taxotere-Administered weekly for 1 hour (6 doses)
- Radiation Therapy (XRT) -5 days a week for 6 weeks
- Exam under anesthesia
- Neck Dissection (if indicated)
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
MTD of weekly Taxotere
时间窗: 6 Weeks
Number of Participants of with Severe Adverse Events
时间窗: 6 Weeks
次要结局
未报告次要终点
研究者
Robert I. Haddad, MD
Haddad, Robert MD
Dana-Farber Cancer Institute