Interval Between Neoadjuvant Therapy and Surgery in the Treatment of Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 911
- 试验地点
- 1
- 主要终点
- Distal resection margin (DRM)
研究概览
简要总结
The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.
详细描述
In the treatment of locally advanced rectal cancer, an optimal interval between neoadjuvant therapy and surgery might improve oncological outcomes. Besides, those patients who achieve a good response might benefit from active surveillance, avoiding surgical comorbidities. This optimal interval is yet to be defined. This study will aim to better define the role of time interval between the end of neoadjuvant therapy (NAT) and TME in Spanish regions, together with analyzing the importance of restaging MRI and define the basis for implementing a "watch and wait" protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging.
- •Patients treated with long-course neoadjuvant chemoradiotherapy (nCRT).
- •Patients treated with short-course radiotherapy with delayed surgery.
- •Clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) determined by rectal cancer protocol magnetic resonance imaging
排除标准
- •Intolerance or contraindication to planned NAT.
- •Patients who have not finished NAT for any reason.
- •Patients with unknown cT or cM.
- •Tumors previously treated with local excision or with distant metastatic disease.
结局指标
主要结局
Distal resection margin (DRM)
时间窗: 2000-2019
Described as free (DRM \>1 mm)
Quality of the specimen
时间窗: 2000-2019
Described as complete or incomplete
Pathological response
时间窗: 2000-2019
Grade as complete
Circumferential margin (CRM)
时间窗: 2000-2019
Described as free (CRM \>1 mm)
次要结局
未报告次要终点