Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Conditions
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Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging, General Surgery, Cancer

Intervention / Treatment
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* Other: Preoperative MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Preoperative CT scan<br>CT-imaging of chest and abdomen / pelvis before surgery (standard treatment) | |
| Experimental: Preoperative MRI scan<br>Standard treatment plus an additional MRI scan before surgery | Other: Preoperative MRI scan<br>* Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.<br>|
| No Intervention: Observational<br>Observational only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI. | Direct comparison of proportion of patients staged as high and low risk for recurrence between CT vs MRI findings | 3 years after last recruit | 
| Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI. | Direct comparison of proportion of patients undergoing preoperative treatment or extended surgery between patients staged with CT vs MRI | 3 years after last recruit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk. | Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI | 3 years after last recruit | 
| To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk. | Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI | 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. | Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI | 5 years | 
| To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk | CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI | 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. | Comparison of proportion of patients staged as low vs high risk on CT vs MRI with pathology high and low risk and against outcomes | 3 years after last recruit | 
| To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk. | Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI | 3 years after last recruit | 
| To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk. | Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29) | 1 and 3 years after last recruit | 
| To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk. | Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI | 3 years after last recruit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging, General Surgery, Postoperative Complications