NCT01325649已完成不适用
Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma
Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 1,051 人开始时间: 2009年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,051
- 试验地点
- 1
- 主要终点
- Locoregional recurrence rate
研究概览
简要总结
The objective of the study is to provide proof that a MRI based preoperative radiochemotherapy in patients with locally advanced rectal carcinoma allows limiting RCT to high risk patients without increase of locoregional recurrence rate and decrease of overall survival provided there is a high quality of mesorectal excision.
详细描述
The criteria for application of RCT is the distance of the tumor from mesorectal fascia in preoperative MRI of the pelvis. In case of a T 4 tumor or a tumor with a distance of 1mm of less form mesorectal fascia long-course radiochemotherapy is applied followed by surgery, in all other cases primary surgery is done.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients with histologically confirmed invasive carcinoma of the rectum infiltrating beyond the submucosa (cT3, cT2N+, cM0)
- •Elective surgery
- •Fit for surgery
- •Preoperative MRI of pelvis
排除标准
- •uT1 Tumors
- •provided for local excision
- •previous or synchronous malignant tumors (except squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix)
- •previous irradiation of the pelvis
- •ulcerative colitis or Crohn's disease
结局指标
主要结局
Locoregional recurrence rate
时间窗: Five year
次要结局
- Rate of involvement of circumferential resection margin (pCRM positive of resected specimens(postoperative)
研究者
Theo Junginger
MD
Johannes Gutenberg University Mainz
研究点 (1)
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