Induction Chemotherapy With Taxotere, Cisplatin and 5-Fluorouracil Followed by Concomitant Cetuximab and Radiation for Locoregionally Advanced Squamous Cell Cancer of the Head and Neck: A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Organ Sparing Survival
研究概览
简要总结
More than 50% of Head and Neck cancers are locally advanced at presentation. Although surgery, in combination with other modalities like radiation therapy can achieve 40-50% five year survival rates, resection in the head and neck region can leave patients with poor functional and cosmetic outcomes.
Due to these concerns about quality of life after surgery, there has been a lot of interest in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy and biologics has showed promising results. However, questions still remain about the ideal combination treatment regimen.
Based on assimilation of data from multiple sources, our study tries to identify the role of a potentially highly effective multi-modality regimen based on induction chemotherapy (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent, Cetuximab, and radiation therapy.
详细描述
Patients will be given two cycles of induction chemotherapy with Cisplatin, Docetaxel and Fluorouracil. This will be followed by six weeks of radiation therapy along with Cetuximab. Patients will get two more cycles of chemotherapy with the same agents after the completion of radiation therapy course. Patients will be watched very closely during the trial period, with close follow up of treatment responses and monitoring of any adverse effects.
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
Treatment
Treatment with induction chemotherapy followed by radiation and cetuximab.
干预措施: Leucovorin (Drug)
Treatment
Treatment with induction chemotherapy followed by radiation and cetuximab.
干预措施: Radiotherapy (Radiation)
Treatment
Treatment with induction chemotherapy followed by radiation and cetuximab.
干预措施: Cetuximab (Biological)
Treatment
Treatment with induction chemotherapy followed by radiation and cetuximab.
干预措施: Filgrastim (Drug)
Treatment
Treatment with induction chemotherapy followed by radiation and cetuximab.
干预措施: Erythropoetin (Drug)
Treatment
Treatment with induction chemotherapy followed by radiation and cetuximab.
干预措施: Cisplatin (Drug)
Treatment
Treatment with induction chemotherapy followed by radiation and cetuximab.
干预措施: Fluorouracil (Drug)
Treatment
Treatment with induction chemotherapy followed by radiation and cetuximab.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Organ Sparing Survival
时间窗: 3 years
to determine whether the intervention will prolong survival without needing salvage surgery (organ sparing survival)
次要结局
- Overall Survival(3 years)