Adenocarcinoma, Carcinoma, Neoplasms
Conditions
Keywords
Lower Gastrointestinal Tract, Rectum, Diagnostic Imaging, Magnetic Resonance Imaging, Pelvic Exenteration, Neoplasms, Adenocarcinoma, Carcinoma
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.
Interventions
PROCEDURENew 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.
Sponsors
Pelican Cancer Foundation
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the MRI type of recurrence against clinical outcomes | 1, 3 and 5 years | 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 | 1, 3 and 5 years | 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 | 1, 2, 3 and 5 years | Quality of life assessed using EORTC QLQ-C30 |
| To compare baseline prognostic features against type of recurrence | 3 and 5 years | Correlation of baseline and post treatment prognostic factors on imaging and pathology against type of recurrence. |
| To measure radiology inter-observer agreement for types of recurrence classification | 5 years | Kappa agreement between paired radiologists for type of recurrence |
| To investigate health economic costs of patients with pelvic recurrence against type | Up to 3 years | 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 | Up to 2 years | Correlation of dose, type and distribution of radiotherapy against anatomic sites and aetiology of recurrence as seen on MRI |
| To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence | Up to 2 years | The number of compartments predicted as involved on MRI against the number of compartments reported on the corresponding pathology specimens |
Countries
Norway, United Kingdom
Contacts
Primary ContactCaroline Martin
Backup ContactSyvella Ellis
Outcome results
None listed