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NCT Number: NCT02292641

Beyond TME Origins

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.

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Key information

Conditions

Neoplasms Adenocarcinoma Carcinoma Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. To measure radiology inter-observer agreement for types of recurrence classification

    Time frame: 5 years

    Kappa agreement between paired radiologists for type of recurrence

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Martin

CONTACT

[email protected]

+44 (0) 7749 655 817

Syvella Ellis

CONTACT

[email protected]

+44 (0) 7732 315 234

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Pelican Cancer Foundation

Registry information

Official study title

Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

Important dates

Study start
2014
Primary completion
2026
Study completion
2031
First posted
Nov 17, 2014
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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