Beyond TME Origins

Neoplasms Clinical Trial

Official title:

Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02292641
• Other study ID #: DOCUMAS: 17HH4158
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2014
• Est. completion date: December 2029

Study information

• Verified date: August 2023
• Source: Imperial College London
• Contact: Caroline Martin
• Phone: +44 (0) 7749 655 817
• Email: c.martin1[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 383
• Est. completion date: December 2029
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo
United Kingdom	St Mark's Hospital	Harrow	London
United Kingdom	Churchill Hospital	Oxford	Oxfordshire
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	Sutton

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Pelican Cancer Foundation

Countries where clinical trial is conducted

Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years
Secondary	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.	3 and 5 years
Secondary	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	1, 3 and 5 years
Secondary	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	1, 3 and 5 years
Secondary	To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life	Quality of life assessed using EORTC QLQ-C30	1, 2, 3 and 5 years
Secondary	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	Up to 2 years
Secondary	To measure radiology inter-observer agreement for types of recurrence classification	Kappa agreement between paired radiologists for type of recurrence	5 years
Secondary	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	Up to 3 years
Secondary	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	Up to 2 years