Beyond TME Origins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorImperial College London
About this trial
All patients with recurrent colorectal cancer in the pelvis are eligible. The original primary tumour staging scans and resected surgical specimen needs to be available. Patients' recurrence will be staged using our proposed MRI classification. We will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. We will record treatment for the recurrence, and patients will be followed up for three years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice
Has a confirmed diagnosis of recurrent pelvic colorectal cancer
Has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum
Are able to undergo high resolution MRI for staging prior to treatment decisions
Disqualifiers
Have irresectable extra-pelvic metastatic disease
Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and/or CT for colon and sigmoid cancers) are unavailable
Original preoperative, surgical and adjuvant treatment has not been documented or is unavailable
Trial design
Design model
Single group
Treatments tested in this trial
New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery
Procedure/SurgeryCurrently there are no validated criteria or guidelines for judging whether advanced primary or recurrent colorectal cancer can be successfully removed and for selecting which patients should undergo this form of more radical surgery as is exenterative surgery. We are proposing that by validating the detailed evaluation of imaging of the tumour distribution within the pelvis using a new radiological staging classification, this will enable clear selection criteria to be established and will improve surgical planning.
Treatment groups
383 Participants
are divided into 1 treatment groupGroup A: Patients with pelvic recurrence from primary colorectal cancerOther 1 intervention
Trial outcomes
Primary outcomes
1
To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system.
An increase of 20% in R0 resection (from 55% to 75%) for locally recurrent rectal cancers with the use of the proposed staging system
Time frame
3 yearsSecondary outcomes
1
To compare baseline prognostic features against type of recurrence
Correlation of baseline and post treatment prognostic factors on imaging and pathology against type of recurrence.
Time frame
3 and 5 years2
To compare the MRI type of recurrence against clinical outcomes
Proportion of patients with survival \>12mths according to type of recurrence as described on MRI
Time frame
1, 3 and 5 years3
To compare the MRI compartment(s) distribution of recurrence against clinical outcomes
Proportion of patients with survival \>12mths according to compartment(s) of recurrence as described on MRI
Time frame
1, 3 and 5 years4
To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life
Quality of life assessed using EORTC QLQ-C30
Time frame
1, 2, 3 and 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
Pelican Cancer Foundation
Collaborator
Source ClinicalTrials.gov