Beyond TME Origins

Study Overview
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Brief Summary
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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.

Detailed Description
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A prospective and retrospective cohort study to improve surgical and treatment planning using an imaging assessment proforma of advanced and recurrent colorectal cancers. This involves the implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Official Title
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Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

Conditions
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Neoplasms, Adenocarcinoma, Carcinoma

Intervention / Treatment
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* Procedure: New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Have provided written informed consent to participate in the study Be aged 16 years or over Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with pelvic recurrence from primary colorectal cancer<br>Implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning. | Procedure: New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery<br>* Currently 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 and 5 years | 
| 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 | 1, 3 and 5 years | 
| 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 | 1, 3 and 5 years | 
| To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life | Quality of life assessed using EORTC QLQ-C30 | 1, 2, 3 and 5 years | 
| To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence | The number of compartments predicted as involved on MRI against the number of compartments reported on the corresponding pathology specimens | Up to 2 years | 
| To measure radiology inter-observer agreement for types of recurrence classification | Kappa agreement between paired radiologists for type of recurrence | 5 years | 
| To investigate health economic costs of patients with pelvic recurrence against type | Healthcare costs using NHS Reference Costs combined with health resource utilization and QoL data | Up to 3 years | 
| To map original radiotherapy volumes (including integrated boosts) against types of recurrence | Correlation of dose, type and distribution of radiotherapy against anatomic sites and aetiology of recurrence as seen on MRI | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Gastrointestinal Tract, Rectum, Diagnostic Imaging, Magnetic Resonance Imaging, Pelvic Exenteration, Neoplasms, Adenocarcinoma, Carcinoma