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Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

ConditionsCancerColorectal NeoplasmsColon, SigmoidMagnetic Resonance ImagingGeneral Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorImperial College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative MRI scan

    Other intervention

    Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.

Treatment groups

244 Participants
are divided into 3 treatment groups
Group A: Preoperative CT scanNo intervention 0 interventions
Group B: Preoperative MRI scanExperimental treatment 1 intervention
Group C: ObservationalNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
3 years after last recruit
2

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

Time frame
3 years after last recruit

Secondary outcomes

1

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

Time frame
3 years after last recruit
2

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

Time frame
1 and 3 years after last recruit
3

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

Time frame
5 years
4

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

Time frame
3 years after last recruit

Other outcomes

Sponsors and contacts

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Imperial College London

Lead sponsor

Pelican Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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