Beyond TME Origins

Not Applicable

Recruiting

• Conditions: Neoplasms; Adenocarcinoma; Carcinoma
• Interventions: Procedure: New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery

• Registration Number: NCT02292641
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-05-02
• Study Start: 2014-09-25
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 383

Inclusion Criteria

1. Had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice
2. Has a confirmed diagnosis of recurrent pelvic colorectal cancer
3. Has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum
4. Are able to undergo high resolution MRI for staging prior to treatment decisions
5. Have provided written informed consent to participate in the study
6. Be aged 16 years or over

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Exclusion Criteria

1. Have irresectable extra-pelvic metastatic disease
2. Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and/or CT for colon and sigmoid cancers) are unavailable
3. Original preoperative, surgical and adjuvant treatment has not been documented or is unavailable

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with pelvic recurrence from primary colorectal cancer	New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery	Implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Primary Outcome Measures

Name	Time	Method
To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system.	3 years	An increase of 20% in R0 resection (from 55% to 75%) for locally recurrent rectal cancers with the use of the proposed staging system

Secondary Outcome Measures

Name	Time	Method
To compare the MRI compartment(s) distribution of recurrence against clinical outcomes	1, 3 and 5 years	Proportion of patients with survival \>12mths according to compartment(s) of recurrence as described on MRI
To compare baseline prognostic features against type of recurrence	3 and 5 years	Correlation of baseline and post treatment prognostic factors on imaging and pathology against type of recurrence.
To compare the MRI type of recurrence against clinical outcomes	1, 3 and 5 years	Proportion of patients with survival \>12mths according to type of recurrence as described on MRI
To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life	1, 2, 3 and 5 years	Quality of life assessed using EORTC QLQ-C30
To measure radiology inter-observer agreement for types of recurrence classification	5 years	Kappa agreement between paired radiologists for type of recurrence
To map original radiotherapy volumes (including integrated boosts) against types of recurrence	Up to 2 years	Correlation of dose, type and distribution of radiotherapy against anatomic sites and aetiology of recurrence as seen on MRI
To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence	Up to 2 years	The number of compartments predicted as involved on MRI against the number of compartments reported on the corresponding pathology specimens
To investigate health economic costs of patients with pelvic recurrence against type	Up to 3 years	Healthcare costs using NHS Reference Costs combined with health resource utilization and QoL data

Trial Locations

Locations (4)

St Mark's Hospital; 🇬🇧 Harrow, London, United Kingdom

Royal Marsden Hospital NHS Foundation Trust; 🇬🇧 Sutton, United Kingdom

Oslo University Hospital; 🇳🇴 Oslo, Norway

Churchill Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom