Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 32
- 主要终点
- Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
研究概览
简要总结
Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Patient are randomised to the control arm which the standard care of preoperative CT imaging and subsequent discussion by the Multidisciplinary Team or the interventional arm which has the additional use of MRI imaging and subsequent discussion by the Multidisciplinary Team. Patients are followed up at 1 and 3 years together with QoL questionnaires.
详细描述
A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Have a suspected or proven sigmoid colon adenocarcinoma
- •Is eligible for curative treatment
- •Has no irresectable metastatic disease
- •MRI can be reviewed by an MDT prior to surgery
- •Has no decision regarding radical treatment
- •Have provided written informed consent to participate in the study
- •Be aged 16 years or over
排除标准
- •Have metastatic disease (including resectable liver metastases)
- •Have a synchronous second malignancy
- •Are contraindicated for MRI
- •Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR<30)
- •Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy
结局指标
主要结局
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
时间窗: 3 years after last recruit
Direct comparison of proportion of patients staged as high and low risk for recurrence between CT vs MRI findings
Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI.
时间窗: 3 years after last recruit
Direct comparison of proportion of patients undergoing preoperative treatment or extended surgery between patients staged with CT vs MRI
次要结局
- To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.(1 and 3 years after last recruit)
- To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI.(3 years after last recruit)
- To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk.(3 years after last recruit)
- To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk.(1 and 3 years after last recruit)
- To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk.(5 years)
- To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk.(3 years after last recruit)
- To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.(3 years after last recruit)
- To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk(3 years after last recruit)