NCT04679597已完成不适用
Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- pathological complete response
研究概览
简要总结
In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven locally advanced rectal cancer and
- •the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node.
排除标准
- •distant metastases,
- •concomitant malignancy,
- •inflammatory bowel disease, or
- •malabsorption syndrome.
研究组 & 干预措施
total neoadjuvant therapy
Total neoadjuvant therapy consisted of 12 weeks of induction chemotherapy with CAPOX or FOLFOX, chemoradiotherapy with capecitabine and six to eight weeks of consolidation chemotherapy with CAPOX or FOLFOX prior to surgery.
干预措施: Capecitabine (Drug)
standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
干预措施: Capecitabine (Drug)
结局指标
主要结局
pathological complete response
时间窗: during surgery
pathological complete response is defined as the absence of tumor cells in the surgical resection
次要结局
- Neoadjuvant rectal cancer score(during treatment, assessed up to 10 days)
研究者
相似试验
Unknown
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