Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Cancer Clinical Trial

— IMPRESS  

Official title:

Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02222844
• Other study ID #: DOCUMAS: 23HH8201
• Status: Recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2027

Study information

• Verified date: August 2023
• Source: Imperial College London
• Contact: Caroline Martin
• Phone: +44 (0) 7749 655 817
• Email: c.martin1[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Preoperative MRI scan
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.

Locations

Country	Name	City	State
United Kingdom	Chesterfield Royal	Chesterfield	Derbyshire
United Kingdom	Leighton Hospital	Crewe	Cheshire
United Kingdom	North Manchester General Hospital	Crumpsall	Manchester
United Kingdom	Harrogate District Hospital	Harrogate	North Yorkshire
United Kingdom	Hinchingbrooke Hospital	Huntingdon	Cambridgeshire
United Kingdom	Maidstone Hospital	Maidstone	Kent
United Kingdom	Queen Elizabeth the Queen Mother Hospital	Margate	Kent
United Kingdom	St Mark's Hospital	Middlesex	Harrow
United Kingdom	Queen Alexandra Hospital	Portsmouth	Hampshire
United Kingdom	Salisbury District Hospital	Salisbury	Whiltshire
United Kingdom	University Hospital of North Tees	Stockton-on-Tees	County Durham
United Kingdom	Royal Marsden Hospital	Sutton	Surrey
United Kingdom	Musgrove Park Hospital	Taunton	Somerset
United Kingdom	Croydon University Hospital	Thornton Heath	Croydon
United Kingdom	University Hospital of South Manchester & Manchester Royal Infirmary	Wythenshawe	Manchester
United Kingdom	Yeovil District Hospital	Yeovil	Somerset

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Pelican Cancer Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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