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Beyond TME Origins

Primary Purpose

Neoplasms, Adenocarcinoma, Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Lower Gastrointestinal Tract, Rectum, Diagnostic Imaging, Magnetic Resonance Imaging, Pelvic Exenteration, Neoplasms, Adenocarcinoma, Carcinoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, 18 years of age or older
Patients with confirmed primary locally advanced or recurrent rectal cancer who will undergo pelvic exenterative surgery in the two institutions
Patients with the diagnosis of recurrent rectal cancer by serial imaging staging MRI Pelvis, contrast enhanced staging CT and PET/CT where available performed as a standard of care for locoregional and distant disease
Informed consent obtained by the institutions

Exclusion Criteria:

Patients for whom an MRI study is contraindicated
Patients with anal cancer (squamous cell carcinoma and non-adenocarcinoma malignancies)
Patients with irresectable metastatic disease or irresectable synchronous second malignancy
Patients with poor performance status to undergo surgery
Patients with poorly controlled diabetes (for 18F FDG PET-CT)

Sites / Locations

Oslo University HospitalRecruiting
St Mark's HospitalRecruiting
Churchill HospitalRecruiting
Royal Marsden Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with pelvic recurrence from primary colorectal cancer

Arm Description

Implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

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

To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life

Quality of life assessed using EORTC QLQ-C30

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

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

Kappa agreement between paired radiologists for type of recurrence

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

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

Full Information

NCT ID

NCT02292641

First Posted

May 2, 2014

Last Updated

August 30, 2023

Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02292641

Brief Title

Beyond TME Origins

Official Title

Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 25, 2014 (Actual)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Adenocarcinoma, Carcinoma

Keywords

Lower Gastrointestinal Tract, Rectum, Diagnostic Imaging, Magnetic Resonance Imaging, Pelvic Exenteration, Neoplasms, Adenocarcinoma, Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

383 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with pelvic recurrence from primary colorectal cancer

Arm Type

Other

Arm Description

Implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system.

Description

An increase of 20% in R0 resection (from 55% to 75%) for locally recurrent rectal cancers with the use of the proposed staging system

Time Frame

3 years

Secondary Outcome Measure Information:

Title

To compare baseline prognostic features against type of recurrence

Description

Correlation of baseline and post treatment prognostic factors on imaging and pathology against type of recurrence.

Time Frame

3 and 5 years

Title

To compare the MRI type of recurrence against clinical outcomes

Description

Proportion of patients with survival >12mths according to type of recurrence as described on MRI

Time Frame

1, 3 and 5 years

Title

To compare the MRI compartment(s) distribution of recurrence against clinical outcomes

Description

Proportion of patients with survival >12mths according to compartment(s) of recurrence as described on MRI

Time Frame

1, 3 and 5 years

Title

To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life

Description

Quality of life assessed using EORTC QLQ-C30

Time Frame

1, 2, 3 and 5 years

Title

To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence

Description

The number of compartments predicted as involved on MRI against the number of compartments reported on the corresponding pathology specimens

Time Frame

Up to 2 years

Title

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

Description

Kappa agreement between paired radiologists for type of recurrence

Time Frame

5 years

Title

To investigate health economic costs of patients with pelvic recurrence against type

Description

Healthcare costs using NHS Reference Costs combined with health resource utilization and QoL data

Time Frame

Up to 3 years

Title

To map original radiotherapy volumes (including integrated boosts) against types of recurrence

Description

Correlation of dose, type and distribution of radiotherapy against anatomic sites and aetiology of recurrence as seen on MRI

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Martin

Phone

+44 (0) 7749 655 817

c.martin1@imperial.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Syvella Ellis

Phone

+44 (0) 7732 315 234

giclinicaltrials@imperial.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gina Dr Brown, MD

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

ZIP/Postal Code

N-0424

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arne Solbakken

ARMSOL@ous-hf.no

First Name & Middle Initial & Last Name & Degree

Kjersti Flatmark

Facility Name

St Mark's Hospital

City

Harrow

State/Province

London

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ian Jenkins

i.jenkins@nhs.net

First Name & Middle Initial & Last Name & Degree

Pooja Datt

pooja.datt@nhs.net

Facility Name

Churchill Hospital

City

Oxford

State/Province

Oxfordshire

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chris Cunningham

Chris.Cunningham@ouh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Madeleine Thyssen

Madeleine.Thyssen@ouh.nhs.uk

Facility Name

Royal Marsden Hospital NHS Foundation Trust

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cordelia Grant

giclinicaltrials@imperial.ac.uk

First Name & Middle Initial & Last Name & Degree

Christos Kontovounisios, MD

12. IPD Sharing Statement

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Beyond TME Origins

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