NeoplasmsNCT02292641
Beyond TME Origins
A study testing New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery in people with Neoplasms and Adenocarcinoma, run by Imperial College London at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neoplasms, Adenocarcinoma, Carcinoma
- What is being tested?
- New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Sep 2014to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United Kingdom3 sites, 3 recruiting
- Recruiting
St Mark's Hospital
Harrow, London
Ian Jenkins, i.jenkins@nhs.net
Pooja Datt, pooja.datt@nhs.net
- Recruiting
Churchill Hospital
Oxford, Oxfordshire
Chris Cunningham, Chris.Cunningham@ouh.nhs.uk
Madeleine Thyssen, Madeleine.Thyssen@ouh.nhs.uk
- Recruiting
Royal Marsden Hospital NHS Foundation Trust
Sutton, SM2 5PT
Cordelia Grant, giclinicaltrials@imperial.ac.uk
Christos Kontovounisios, MD
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, N-0424
Arne Solbakken, ARMSOL@ous-hf.no
Kjersti Flatmark
About this study
Official title: 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.
Read the 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.
- Conditions
- Neoplasms, Adenocarcinoma, Carcinoma
- Being tested
- New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery
- Keywords
- Lower Gastrointestinal Tract, Rectum, Diagnostic Imaging, Magnetic Resonance Imaging, Pelvic Exenteration, Neoplasms, Adenocarcinoma, Carcinoma
- Medical subject headings
- Neoplasms, Adenocarcinoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (8)
To compare baseline prognostic features against type of recurrence
Correlation of baseline and post treatment prognostic factors on imaging and pathology against type of recurrence.
Measured: 3 and 5 years
To compare the MRI type of recurrence against clinical outcomes
Proportion of patients with survival >12mths according to type of recurrence as described on MRI
Measured: 1, 3 and 5 years
To compare the MRI compartment(s) distribution of recurrence against clinical outcomes
Proportion of patients with survival >12mths according to compartment(s) of recurrence as described on MRI
Measured: 1, 3 and 5 years
To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life
Quality of life assessed using EORTC QLQ-C30
Measured: 1, 2, 3 and 5 years
To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence
The number of compartments predicted as involved on MRI against the number of compartments reported on the corresponding pathology specimens
Measured: Up to 2 years
To measure radiology inter-observer agreement for types of recurrence classification
Kappa agreement between paired radiologists for type of recurrence
Measured: 5 years
To investigate health economic costs of patients with pelvic recurrence against type
Healthcare costs using NHS Reference Costs combined with health resource utilization and QoL data
Measured: Up to 3 years
To map original radiotherapy volumes (including integrated boosts) against types of recurrence
Correlation of dose, type and distribution of radiotherapy against anatomic sites and aetiology of recurrence as seen on MRI
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study start25 Sep 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 383 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Dr Brown, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292641
- Sponsor's protocol ID
- DOCUMAS: 17HH4158
- Status last verified
- Oct 2024
- First submitted
- 2 May 2014
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Origins of Pelvic Recurrence in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02292641
- Acronym / sponsor ID
- DOCUMAS: 17HH4158
- Conditions
- Neoplasms, Adenocarcinoma, Carcinoma
- Keywords
- Lower Gastrointestinal Tract, Rectum, Diagnostic Imaging, Magnetic Resonance Imaging, Pelvic Exenteration, Neoplasms, Adenocarcinoma, Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 383 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Study start
- 25 Sep 2014 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pelvic recurrence from primary colorectal cancer | Other | Procedure: New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgeryImplementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgeryCurrently 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. | Procedure or surgery | Patients with pelvic recurrence from primary colorectal cancer |
Primary outcome
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
8 secondary outcomes
To compare baseline prognostic features against type of recurrence
Time frame: 3 and 5 years
To compare the MRI type of recurrence against clinical outcomes
Time frame: 1, 3 and 5 years
To compare the MRI compartment(s) distribution of recurrence against clinical outcomes
Time frame: 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
To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence
Time frame: Up to 2 years
To measure radiology inter-observer agreement for types of recurrence classification
Time frame: 5 years
To investigate health economic costs of patients with pelvic recurrence against type
Time frame: Up to 3 years
To map original radiotherapy volumes (including integrated boosts) against types of recurrence
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gina Dr Brown, MD principal investigator
Imperial College London
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery in people with Neoplasms and Adenocarcinoma, run by Imperial College London at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Martin (+44 (0) 7749 655 817, c.martin1@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.