Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer: a Multicenter Comparative Study With Rectal Preservation as Supported by Surgeon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- 3-year overall survival
研究概览
简要总结
Though refusal of radical surgery was often happened in rectal cancer patient after neoadjuvant chemoradiotherapy, little is currently known about the actual oncologic outcome of it. Thus the investigators designed this study to compare the oncologic outcome of unintended rectal preservation with intended rectal preservation by surgeon.
详细描述
The investigators identified patients whose organ were preserved by non-operative management or local excision after neoadjuvant chemoradiotherapy for mid to low rectal cancer. Then, the patients were categorized into two groups according to the agreement on omitting radical surgery (rectal preservation). When treatment decision was agreed by their surgeon, the patients were categorized as intended rectal preservation. When there was disagreement by surgeon on rectal preservation, then the patients categorized as unintended rectal preservation. Oncologic outcome was compared between two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •biopsy proven rectal cancer (anal verge ≤ 10cm)
- •neoadjuvant radiotherapy or chemoradiotherapy
- •no radical surgery after neoadjuvant therapy
排除标准
- •other malignant disease
- •other fatel disease
- •incompletion of half of radiotherapy course
- •metastasis on initial presentation
结局指标
主要结局
3-year overall survival
时间窗: from date of completion of chemoradiotherapy until the date of death from any cause, whichever came first, assessed at 31th December 2017 by checking expire date of a resident registration number
Overall survival rate at 3-year after completion of chemoradiotherapy
次要结局
未报告次要终点
研究者
Sung-Bum Kang
Colorectal Surgeon, University Professor
Seoul National University Hospital