Beyond TME Origins

October 16, 2024 updated by: Imperial College London

Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

383

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional 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
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
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.

What is the study measuring?

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.
Time Frame: 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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare baseline prognostic features against type of recurrence
Time Frame: 3 and 5 years
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
Time Frame: 1, 3 and 5 years
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
Time Frame: 1, 3 and 5 years
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
Time Frame: 1, 2, 3 and 5 years
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
Time Frame: Up to 2 years
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
Time Frame: 5 years
Kappa agreement between paired radiologists for type of recurrence
5 years
To investigate health economic costs of patients with pelvic recurrence against type
Time Frame: Up to 3 years
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
Time Frame: Up to 2 years
Correlation of dose, type and distribution of radiotherapy against anatomic sites and aetiology of recurrence as seen on MRI
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation

Investigators

  • Principal Investigator: Gina Dr Brown, MD, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimated)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOCUMAS: 17HH4158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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