Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Not Applicable

Recruiting

• Conditions: Colon, Sigmoid; General Surgery; Colorectal Neoplasms; Magnetic Resonance Imaging; Cancer
• Interventions: Other: Preoperative MRI scan

• Registration Number: NCT02222844
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

1. Have a suspected or proven sigmoid colon adenocarcinoma
2. Is eligible for curative treatment
3. Has no irresectable metastatic disease
4. MRI can be reviewed by an MDT prior to surgery
5. Has no decision regarding radical treatment
6. Have provided written informed consent to participate in the study
7. Be aged 16 years or over

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Exclusion Criteria

1. Have metastatic disease (including resectable liver metastases)
2. Have a synchronous second malignancy
3. Are contraindicated for MRI
4. Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR<30)
5. Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative MRI scan	Preoperative MRI scan	Standard treatment plus an additional MRI scan before surgery

Primary Outcome Measures

Name	Time	Method
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.	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.	3 years after last recruit	Direct comparison of proportion of patients undergoing preoperative treatment or extended surgery between patients staged with CT vs MRI

Secondary Outcome Measures

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

Trial Locations

Locations (16)

Salisbury District Hospital; 🇬🇧 Salisbury, Whiltshire, United Kingdom

Musgrove Park Hospital; 🇬🇧 Taunton, Somerset, United Kingdom

Leighton Hospital; 🇬🇧 Crewe, Cheshire, United Kingdom

Yeovil District Hospital; 🇬🇧 Yeovil, Somerset, United Kingdom

Croydon University Hospital; 🇬🇧 Thornton Heath, Croydon, United Kingdom

University Hospital of South Manchester & Manchester Royal Infirmary; 🇬🇧 Wythenshawe, Manchester, United Kingdom

Harrogate District Hospital; 🇬🇧 Harrogate, North Yorkshire, United Kingdom

Maidstone Hospital; 🇬🇧 Maidstone, Kent, United Kingdom

North Manchester General Hospital; 🇬🇧 Crumpsall, Manchester, United Kingdom

University Hospital of North Tees; 🇬🇧 Stockton-on-Tees, County Durham, United Kingdom

Chesterfield Royal; 🇬🇧 Chesterfield, Derbyshire, United Kingdom

Queen Elizabeth the Queen Mother Hospital; 🇬🇧 Margate, Kent, United Kingdom

St Mark's Hospital; 🇬🇧 Middlesex, Harrow, United Kingdom

Hinchingbrooke Hospital; 🇬🇧 Huntingdon, Cambridgeshire, United Kingdom

Royal Marsden Hospital; 🇬🇧 Sutton, Surrey, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Portsmouth, Hampshire, United Kingdom