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Beyond TME Origins

Sponsor: Imperial College London

NCT ID: NCT02292641

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery (procedure)
How long the study runs
Study runs about 207 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor

In plain English

This study, called 'Beyond TME Origins', is for people whose bowel cancer (cancer of the colon or rectum) has come back in the pelvis after earlier surgery. It is run by Imperial College London. People taking part have a high-resolution MRI (magnetic resonance imaging) scan, which gives detailed pictures, before doctors make decisions about treatment.

Who can take part

  • You have had a type of bowel cancer called adenocarcinoma, confirmed by a tissue sample (biopsy) taken during your normal hospital care.
  • Tests show your bowel cancer has come back in the pelvis (the lower part of the tummy, between the hips).
  • You have already had surgery to remove your first bowel cancer in the colon, sigmoid colon (the lower part of the bowel before the rectum) or rectum (back passage).
  • You are able to have a high-resolution MRI scan before decisions about treatment are made.
  • You have signed a written form to say you agree to take part.
  • You are aged 16 or over.

Who may not be able to

  • Your cancer has spread to parts of the body outside the pelvis and cannot be removed with surgery.
  • Your original scans (MRI for rectal and sigmoid cancers, and/or CT, meaning computed tomography, for colon and sigmoid cancers) cannot be found.
  • There are no written records of the treatment you had before your first surgery, the surgery itself, or any treatment you had afterwards.

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Taking part involves a high-resolution MRI scan before treatment decisions and signing a consent form; how many visits and how long the study lasts are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
16 Years and over
Who
All
Number of participants
383
Started
2014-09-25
Last checked
2024-10

Plain English Summary

What is this study?

  • • Testing a new treatment for neoplasms
  • • NA - 383 participants
  • • All patients with recurrent colorectal cancer in the pelvis are eligible

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with neoplasms

Where?

  • • Harrow - St Mark's Hospital
  • • Oxford - Churchill Hospital
  • • Sutton - Royal Marsden Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

NeoplasmsAdenocarcinomaCarcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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 agreement to take part to participate in the study

Who cannot take part

  • ✗Have irresectable extra-pelvic that has spread disease
  • ✗Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and/or CT for colon...
  • ✗Original preoperative, surgical and after surgery treatment has not been documented or is unavailable
See the full criteria
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

Where Is This Study? (3 UK sites)

St Mark's Hospital

Harrow, United Kingdom

Recruiting
Site contact (verified)

Churchill Hospital

Oxford, United Kingdom

Recruiting
Site contact (verified)

Royal Marsden Hospital NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Christos Kontovounisios, MDPrincipal Investigator

How to Get in Touch

Caroline Martin

Sponsor contact

CONTACT

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

Syvella Ellis

Sponsor contact

CONTACT

+44 (0) 7732 315 234 giclinicaltrials@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-10