Beyond TME Origins

NCT ID: NCT02292641

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-25

Study Completion Date

2031-12-31

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.

Conditions

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Neoplasms Adenocarcinoma Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pelican Cancer Foundation

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gina Dr Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

St Mark's Hospital

Harrow, London, United Kingdom

Site Status RECRUITING

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Site Status RECRUITING

Royal Marsden Hospital NHS Foundation Trust

Sutton, , United Kingdom

Site Status RECRUITING

Countries

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Norway United Kingdom

Central Contacts

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Caroline Martin

Role: CONTACT

+44 (0) 7749 655 817

Syvella Ellis

Role: CONTACT

+44 (0) 7732 315 234

Facility Contacts

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Arne Solbakken

Role: primary

Ian Jenkins

Role: primary

Pooja Datt

Role: backup

Chris Cunningham

Role: primary

Madeleine Thyssen

Role: backup

Cordelia Grant

Role: primary

Other Identifiers

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DOCUMAS: 17HH4158

Identifier Type: -

Identifier Source: org_study_id

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