Recruiting NCT02292641

Beyond TME Origins

No phase Interventional Neoplasms Adenocarcinoma Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery.
Who it may be relevant to: Registry conditions: Neoplasms, Adenocarcinoma, Carcinoma. Basic parameters: from 16 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Norway, United Kingdom
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

Overview

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.

Interventions

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 impr

Primary outcome measures

To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system. [Time frame: 3 years]

Secondary outcome measures (8)

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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United Kingdom · 3 centers

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

Norway · 1 center

Oslo University Hospital — Oslo

Identifiers

NCT: NCT02292641 · DOCUMAS: 17HH4158

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗