The Impact of Patient Positioning and Use of Belly Board on Small Bowel and Urinary Bladder Volume Irradiated in Patients Receiving Radiotherapy for Rectal Cancer: A Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose and irradiated volume of small bowel and urinary bladder
研究概览
简要总结
Radiotherapy has a significant impact on local control, disease free survival and overall survival in patients with rectal cancer T2, N1, M0 and T3-4, any N, M0. Treatment is accompanied by side effects, mainly due to the inclusion of the small bowel and urinary bladder in the treatment fields.
Two major modalities have been pursued to reduce the volume of small intestine and urinary bladder in treatment volume. One is a surgical procedure, such as absorbable mesh. These procedures have failed implementation in daily clinical practice. The second modality aims to save the small intestine and urinary bladder from the toxicity of radiotherapy by modulating the radiotherapy planning procedure. Using the belly board and changing the standard position from supine to prone could achieve this aim; in part due to gravitational displacement of the bowel. Several studies have evaluated the impact of positioning and use of belly board in patients receiving pelvis irradiation for rectal cancer. The results are inconclusive, but the prone position with belly board appears promising.
This study carefully evaluates the impact of patient's positioning and belly board on dose volume histogram of small bowel and urinary bladder
详细描述
This is a prospective non-randomized open study to evaluate the impact of patient's positioning and use of belly board in rectal radiotherapy.
In contrast to previous studies, the clinical target volume and organ at risk will be contouring for three-dimensional planning. With the aid of modern imaging, correlation can be obtained between dose and volume (DVH) since both parameters have an impact on organ tolerance to ionizing radiation.
Thirty patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative will be included (15 patients from each group).
In addition to radiotherapy, the patients will receive concomitant chemotherapy.
Chemotherapy: The chemotherapy will consist of one of the following:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative
排除标准
- •No exclusion
结局指标
主要结局
Dose and irradiated volume of small bowel and urinary bladder
时间窗: 30 months
次要结局
未报告次要终点