Beyond TME Origins

NCT02292641 | Recruiting DMC

• 1 other identifier: DOCUMAS: 17HH4158
• Study Type: interventional
• Target: 383
• Locations: 2 countries
• Sites: 4

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.

Conditions

Neoplasms; Adenocarcinoma; Carcinoma

Keywords

Lower Gastrointestinal Tract; Rectum; Diagnostic Imaging; Magnetic Resonance Imaging; Pelvic Exenteration; Neoplasms; Adenocarcinoma; Carcinoma

Outcome Measures

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

  3 years

Secondary Outcomes (8)

• To compare baseline prognostic features against type of recurrence

  3 and 5 years

• To compare the MRI type of recurrence against clinical outcomes

  1, 3 and 5 years

• To compare the MRI compartment(s) distribution of recurrence against clinical outcomes

  1, 3 and 5 years

• To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life

  1, 2, 3 and 5 years

• To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence

  Up to 2 years

Study Arms (1)

Patients with pelvic recurrence from primary colorectal cancer

OTHER

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

Interventions

New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery PROCEDURE

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.

Patients with pelvic recurrence from primary colorectal cancer

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Pelican Cancer Foundation: collaborator

Study Sites (4)

Oslo University Hospital

Oslo, N-0424, Norway

RECRUITING

St Mark's Hospital

Harrow, London, United Kingdom

RECRUITING

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

RECRUITING

Royal Marsden Hospital NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms; Adenocarcinoma; Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Gina Dr Brown, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Martin

CONTACT

+44 (0) 7749 655 817; c.martin1@imperial.ac.uk

Syvella Ellis

CONTACT

+44 (0) 7732 315 234; giclinicaltrials@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: November 17, 2014
• Study Start: September 25, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

NO (1); GB (3)