Investigating the Origins of Pelvic Recurrence in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 383
- 试验地点
- 6
- 主要终点
- To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system.
研究概览
简要总结
All patients with recurrent colorectal cancer in the pelvis are eligible. The original primary tumour staging scans and resected surgical specimen needs to be available. Patients' recurrence will be staged using our proposed MRI classification. We will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. We will record treatment for the recurrence, and patients will be followed up for three years.
详细描述
A prospective and retrospective cohort study to improve surgical and treatment planning using an imaging assessment proforma of advanced and recurrent colorectal cancers. This involves the implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice
- •Has a confirmed diagnosis of recurrent pelvic colorectal cancer
- •Has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum
- •Are able to undergo high resolution MRI for staging prior to treatment decisions
- •Have provided written informed consent to participate in the study
- •Be aged 16 years or over
排除标准
- •Have irresectable extra-pelvic metastatic disease
- •Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and/or CT for colon and sigmoid cancers) are unavailable
- •Original preoperative, surgical and adjuvant treatment has not been documented or is unavailable
结局指标
主要结局
To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system.
时间窗: 3 years
An increase of 20% in R0 resection (from 55% to 75%) for locally recurrent rectal cancers with the use of the proposed staging system
次要结局
- To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence(Up to 2 years)
- To investigate health economic costs of patients with pelvic recurrence against type(Up to 3 years)
- To compare the MRI compartment(s) distribution of recurrence against clinical outcomes(1, 3 and 5 years)
- To compare baseline prognostic features against type of recurrence(3 and 5 years)
- To compare the MRI type of recurrence against clinical outcomes(1, 3 and 5 years)
- To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life(1, 2, 3 and 5 years)
- To measure radiology inter-observer agreement for types of recurrence classification(5 years)
- To map original radiotherapy volumes (including integrated boosts) against types of recurrence(Up to 2 years)