NCT00165269已完成2 期
Mantle Irradiation for Selected Hodgkin's Disease Patients With Stage IA-IIA Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.
研究概览
简要总结
The purpose of this study it to evaluate the effectiveness of radiation therapy limited to above the diaphragm in patients with pathological stage IA-IIA Hodgkin's disease.
详细描述
- Eligble patients will receive a course of radiation therapy directed to above the diaphragm only.
- Patients would have bloodwork and chest x-rays performed 4 times per year for the first two years, 3 times per year for the third year, and 2 times per year for the fourth and fifth years. After five years, yearly check-ups are performed.
- In addition to the above follow-up, patients will receive, once or twice a year for the first 5 years, an abdominal-pelvic CT scan and/or gallium scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Pathologically Stage IA-IIA Hodgkin's disease
- •A negative staging laparotomy including splenectomy, biopsies of liver, paraortic nodal biopsies and palpitation of upper pelvic nodes
- •18 years of age or older
排除标准
- •Patients with large mediastinal adenopathy
- •Patients with LD histology
- •Patients with "B" symptoms
- •Positive laparotomy
- •Subcarinal, hilar, or cardiac lymph node involvement
结局指标
主要结局
To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (4)
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