Colo-rectal Cancer, Rectal Cancer
Conditions
Keywords
early stage, early phase, Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Histopathological Staging, MDT Decision Making, MRI Staging, Quality of Life, Radiotherapy, Rectal preservation, Shared decision making, Significant Rectal Polyps, Transanal Endoscopic Microsurgery, Transanal Minimally Invasive Surgery
Brief summary
When a patient is diagnosed with a rectal (bowel) polyp or cancer, radiology doctors read MRI scans to describe how deeply the cancer invades into the bowel wall (this is the 'stage' of the cancer). In this project, we will teach radiologists to find more early-stage rectal cancers. These are cancers that have only grown partially into the bowel wall. If we succeed, more patients could have these lesions removed by a local procedure that preserves the bowel and avoids the risks and complications of major surgery. We have developed a new method for radiology doctors to read MRI scans, which is more accurate than current practice. Currently only 3/10 of early rectal cancers are found by radiologists but by using our MRI reading system, 9/10 patients can be accurately identified as having early rectal cancer. We have proven that we can teach this method to other radiology doctors whose reports help to accurately inform patients of all possible treatment options, so they can be offered the option of a local procedure. In this initial work we will train radiology doctors in our MRI reading method in 20 hospitals. We will compare MRI reports before and after training to see if an accurate reading method improves treatments choices for patients. We will also determine whether more patients have local procedures after our training. The results of this initial work will help us to apply for national funding for a trial that we can quickly roll out to all NHS hospitals.
Detailed description
Many patients diagnosed with Early Rectal Cancer (ERC) are currently over-treated. Most patients with confirmed ERC will undergo an MRI, but some are not correctly identified in endoscopy and immediately removed. Of those who undergo MRI, 69% are over-staged and undergo major surgery or unnecessary radiotherapy when local excision surgery to preserve the patients rectum, and quality of life, would have been possible. \<10% of patients with ERC are staged accurately and offered local excision, with the majority who are staged as ERC on MRI still undergoing major surgery, likely due to uncertainty in the staging report. Prof Gina Brown developed a more accurate radiological staging system (PRESERVE) or ERC, whereby T2 tumours are identified and classified according to the degree of preservation of the individual layers of the rectal wall. It has been shown that PRESERVE enabled better identification of ERC suitable for local excision from the expected 30% to 89% accuracy. This improved accuracy was replicated in a further study by training a cohort of 12 radiologists. It is predicted that wider adoption of PRESERVE will result in increased organ-preserving surgery from the current rates of 10% to \>50%.
Interventions
DIAGNOSTIC_TESTMRI scan
MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy.
OTHERRadiologist training
Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.
Sponsors
Pelican Cancer Foundation
RM Partners West London Cancer Alliance
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Multicentre, stepped-wedge cluster randomised trial. This pilot study will run for 9 months and utilise a stepped wedge cluster randomised controlled trial design (including transition period). Sites will enter data from the diagnostic and treatment pathways of all rectal cancer patients who are eligible for primary surgical treatment, eg those radiologically staged as less than or equal to T3b or with confirmed as less than or equal to pT2N0 pathological staging. Prior to the trial opening the participating sites will be randomly allocated a number, which will determine the number of months the site will remain in the control and then subsequently the intervention phase of the trial.
Eligibility
Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Have a rectal tumour or suspected tumour less than or equal to T3b on MRI stage or pT2 or less after excision, or 20mm or more on endoscopy with suspicion of malignancy 2. Be aged 16 years or over
Exclusion criteria
1. Have metastatic disease at time of initial staging 2. Have a biopsy-proven rectal malignancy which is not adenocarcinoma 3. Are contraindicated for MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of a training intervention on the accuracy of the tumour staging diagnosis through systematic reporting approach to MRI scans against current (pre intervention) practice. | 1 year | Comparison of the proportion of patients with early rectal cancer who are diagnosed by pathology vs those staged as such by MRI, before and after the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with technically adequacate scans before and after intervention | 1 year | Proportion of patients scanned with high resolution MR in the correct planes |
| Proportion of primary tumour characterised by morphology and other features associated with malignancy before and after intervention | 1 year | Proportion of reports where primary tumour has been characterised by morphology before and after intervention in i) endoscopy, ii) radiology reports before and after intervention |
| Proportion of MRI reports with T substage given before and after intervention | 1 year | Proportion of reports where T substage of primary tumour has been recorded before and after intervention |
| Number of patients identified on imaging as suitable for rectal preservation by local excision | 1 year | Proportion of imaging reports where suitable patients are identified on the report as suitable for rectal preservation by local excision being identified by the radiologist on the report before and after intervention |
| Number of patients identified by MDT as suitable for rectal preservation by local excision | 1 year | Proportion of MDT decisions where patients suitable for rectal preservation by local excision are identified and comparison of treatments offered to patients by the MDT, before and after the intervention |
| Correlation of accuracy in the identification of safe plane of excision for rectal preservation by the radiologist | 1 year | Proportion of patients with \>1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients with \>1mm submucosa preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients undergoing TME that have \<1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention |
| Numebr of patients with R0 by local excision or TME as appropriate | 1 year | Proportion of patients with R0 that have \>1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients with R0 that have\>1mm submucosa preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients undergoing TME with R0 that have \<1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention |
| Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery | 1 year, 3 years, 5 years | Comparison of QoL EORTC QLQ-CR29 scores before and after intervention. Questions relate to difficulty in performing every day tasks answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much' |
| Number of patients without disease and/or without stoma between patients undergoing local excision surgery, compared to those undergoing major surgery | 1 year, 3 years, 5 years | DFS and stoma free survival in patients based on individual pathways before and after intervention |
| Qualitative LARS Questionnaire on Quality of Life of patients undergoing local excision vs major surgery | 1 year, 3 years, 5 years | Comparison of LARS scores before and after intervention. Questions relate to bowel function answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much' |
| Qualitative Questionnaire on Quality of Life of patients undergoing local excision vs major surgery | 1 year, 3 years, 5 years | Comparison of self evaluation of overall health and quality of life scores before and after intervention. Answers are rated from 1 very poor to 7 excellent |
| Comparison of total costs of procedures performed between patients undergoing local excision surgery to those undergoing major surgery | 1 year | Comparison of total costs of hospital procedures performed based on individual pathways before and after intervention |
| Comparison of inpatient costs between patients undergoing local excision surgery to those undergoing major surgery | 1 year | Comparison of cost of inpatient episodes based on individual pathways before and after intervention |
| Comparison of total cost of outpatient visits between patients undergoing local excision surgery to those undergoing major surgery | 1 year | Comparison of total cost of outpatient episodes based on individual pathways before and after intervention |
| Comparison of total community costs between patients undergoing local excision surgery to those undergoing major surgery | 1 year | Comparison of total cost of treatments delivered in the community based on individual pathways before and after intervention |
| Assessment results for the effectiveness of mrSRT after a year from training | 1 year | Determine longevity of training by assessment of radiologists trained with the PRESERVE mrSRT accuracy 1 year after training |
| Identification of histopathological biomarkers to improve selection of patients who can undergo rectal preserving strategies for Early Recal Cancer | 2 months, 1 year, 3 years, 5 years | Comparison of relative % histopathological biomarkers screening panels between patients identified on imaging as suitable for rectal preservation by local excision being identified by the radiologist on the report before and after intervention |
| Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery | 1 year, 3 years, 5 years | Comparison of QoL EORTC QLQ-CR30 scores before and after intervention. Questions relate to the presences of symptoms over the previous week answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much' |
Countries
United Kingdom
Contacts
Primary ContactCaroline Martin
Backup ContactSyvella Ellis
Outcome results
None listed