Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
- Conditions
- Rectal CancerColo-rectal Cancer
- Interventions
- Other: Radiotherapy and surveillanceOther: Surveillance 6 monthlyOther: surveillance 3 montly
- Registration Number
- NCT04103372
- Lead Sponsor
- Imperial College London
- 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%.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Be aged 16 years or over
- Have metastatic disease at time of initial staging
- Have a biopsy-proven rectal malignancy which is not adenocarcinoma
- Are contraindicated for MRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High Risk Radiotherapy and surveillance MR Staged \>1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of \>2. (Margin positive - 0mm to the diathermy margin, Margin positive/or unassessable due to piecemeal removal - 0mm to the tumour margin, Sm3 or Haggitt 4, Poorly differentiated/mucinous, LVI, T2) Patient is considered for surgery, receives radiotherapy and surveillance, with 3 monthly follow-up from date of surgery. Low risk Surveillance 6 monthly MR Staged \>1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 0. (Margin Clear \>0mm from the diathermy margin and Sm1/2 or Haggitt 1/2/3) Six monthly follow up from date of surgery. Moderate Risk - RT&Surveillance Radiotherapy and surveillance MR Staged \>1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 1. (Margin positive -0mm to the diathermy margin, or SM3 or Haggitt 4, or LVI) Patient randomized to receive radiotherapy (RT) and regular surveillance, with 3 monthly follow-up from the date of surgery. Moderate Risk - Surveillance surveillance 3 montly MR Staged \>1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 1. (Margin positive -0mm to the diathermy margin, or SM3 or Haggitt 4, or LVI) Patient randomized to surveillance arm with regular surveillance, with 3 monthly follow-up from the date of surgery. TME (Total mesorectal excision) Surgery Surveillance 6 monthly For patients where it is considered technically feasible to do LE but MR staged\<1mm muscularis preserved, or it is considered not feasible to perform a local excision. Patients undergo TME surgery. Pathology assessment on sample with confirmation of adenocarcinoma. Patient receives 6 monthly follow-up from date of surgery.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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'
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'
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
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
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
Trial Locations
- Locations (23)
Royal Berkshire Hospital
🇬🇧Reading, Berkshire, United Kingdom
Buckinghamshire Healthcare Nhs Trust
🇬🇧Amersham, Buckinghamshire, United Kingdom
University College London Hospitals Nhs Foundation Trust
🇬🇧London, Greater London, United Kingdom
King'S College Hospital Nhs Foundation Trust
🇬🇧London, Greater London, United Kingdom
West Middlesex Hospital
🇬🇧London, Greater London, United Kingdom
Imperial College Healthcare Nhs Trus
🇬🇧London, Greater London, United Kingdom
The Hillingdon Hospitals Nhs Foundation Trust
🇬🇧Uxbridge, Greater London, United Kingdom
Hampshire Hospitals Nhs Foundation Trust
🇬🇧Basingstoke, Hampshire, United Kingdom
Southampton General Hospital
🇬🇧Southampton, Hampshire, United Kingdom
Kent & Canterbury Hospital
🇬🇧Canterbury, Kent, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, Kent, United Kingdom
Westmorland General Hospital
🇬🇧Kendal, Lancashire, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, Leicestershire, United Kingdom
St George'S Hospital
🇬🇧Tooting, London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
Nhs Staffordshire and Stoke-on-Trent Integrated Care Board
🇬🇧Stafford, Staffordshire, United Kingdom
Frimley Health Nhs Foundation Trust
🇬🇧Camberley, Surrey, United Kingdom
St Helier Hospital
🇬🇧Carshalton, Surrey, United Kingdom
Kingston Hospital Nhs Foundation Trust
🇬🇧Kingston Upon Thames, Surrey, United Kingdom
Croydon Health Services Nhs Trust
🇬🇧Thornton Heath, Surrey, United Kingdom
Tonna Hospital
🇬🇧Swansea, Wales, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, Wiltshire, United Kingdom
St Marks Bowel Cancer Screening Centre
🇬🇧Harrow, United Kingdom