A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
研究概览
简要总结
The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.
详细描述
Currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive resection margin. Other patients may receive postoperative radiotherapy only, if they have other risk factors. In our previous study, if there are 3 or more "minor" risk factors, the 3-year recurrence rate was 55%. This outcome was far inferior to patients who had minor risk factors less than 3. Thus, we believe that current postoperative radiotherapy is insufficient for patients with multiple minor risks. A clinical trial should be raised to help these patients. However, the patient number of this group is not enough for large scale, phase 3 trial. So we arranged this phase II trial of postoperative chemoradiation to test and prospectively observe the treatment outcome.
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
- •Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including:
- •Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
- •The tumor is located in the hard palate or the retromolar region.
- •Poorly differentiated cell type.
- •Tumor invasion to the nerve.
- •Tumor invasion to lymphatic vessels.
- •Tumor invasion to the small blood vessels.
- •Tumor invasion to the bone.
- •Tumor invasion to the skin.
- •Depth of tumor invasion ≧ 10mm.
- •Occurred in single lymph node metastasis.
排除标准
- •No or presence of adverse prognostic factor but less than
- •Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading.
- •ECOG performance status >
- •Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease.
- •Women during pregnancy.
结局指标
主要结局
Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
时间窗: 3 year
次要结局
未报告次要终点
研究者
Kang-Hsing Fan
Doctor
Chang Gung Memorial Hospital