Cancer, Colon, Sigmoid, Colorectal Neoplasms, General Surgery, Magnetic Resonance Imaging
Conditions
Keywords
Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging, General Surgery, Postoperative Complications
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.
Interventions
OTHERPreoperative MRI scan
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
Sponsors
Pelican Cancer Foundation
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 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 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 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 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 |
Countries
United Kingdom
Contacts
Primary ContactCaroline Martin
Backup ContactSyvella Ellis
Outcome results
None listed