Clinical trial NCT02222844: Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
Official title: Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Colorectal Neoplasms
Colon, Sigmoid
Magnetic Resonance Imaging
General Surgery
Keywords: Cancer
Colorectal Neoplasms
Colon, Sigmoid
Magnetic Resonance Imaging
General Surgery
Postoperative Complications
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Pelican Cancer Foundation
First posted: 2014-08-21
Enrollment: 244
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
timeFrame: 3 years after last recruit
measure: Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI.
timeFrame: 3 years after last recruit
Secondary outcomes:
measure: To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.
timeFrame: 3 years after last recruit
measure: To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.
timeFrame: 1 and 3 years after last recruit
measure: To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk.
timeFrame: 5 years
measure: To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk
timeFrame: 3 years after last recruit
measure: To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI.
timeFrame: 3 years after last recruit
measure: To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk.
timeFrame: 3 years after last recruit
measure: To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk.
timeFrame: 1 and 3 years after last recruit
measure: To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk.
timeFrame: 3 years after last recruit
Other outcomes:
Locations:
city: Huntingdon
country: United Kingdom
facility: Hinchingbrooke Hospital
state: Cambridgeshire
city: Crewe
country: United Kingdom
facility: Leighton Hospital
state: Cheshire
city: Stockton-on-Tees
country: United Kingdom
facility: University Hospital of North Tees
state: County Durham
city: Thornton Heath
country: United Kingdom
facility: Croydon University Hospital
state: Croydon
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal
state: Derbyshire
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
state: Hampshire
city: Middlesex
country: United Kingdom
facility: St Mark's Hospital
state: Harrow
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: Kent
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital
state: Kent
city: Crumpsall
country: United Kingdom
facility: North Manchester General Hospital
state: Manchester
city: Wythenshawe
country: United Kingdom
facility: University Hospital of South Manchester & Manchester Royal Infirmary
state: Manchester
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: North Yorkshire
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
state: Somerset
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
state: Somerset
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
state: Whiltshire
Study officials:
affiliation: Imperial College London
name: Gina Brown
role: PRINCIPAL_INVESTIGATOR
References: