Improving Diagnosis and Treatment for Patients With Rectal Cancer

Not Applicable

Not yet recruiting

• Conditions: GI Cancer

• Registration Number: NCT07054047
• Lead Sponsor: Imperial College London

Brief Summary

The cancer stage information from scans guides pre-operative treatment and the type of surgery offered. The investigators are studying whether a new Magnetic Resonance Imaging (MRI) staging method can improve the accuracy of prognosis for patients diagnosed with rectal cancer. The investigators will provide consultant radiologists with the know-how to report MRI scans using this new method and compare this with the existing method. This study will test this by comparing how accurately the old versus new method predict the outcomes of patients. The existing method relies on radiologists determining if tumour has spread through the bowel wall or not and whether there are suspected malignant lymph nodes. The new method looks for tumour spread into the veins and whether or not there are tumour deposits. Our previous research has shown that the new method is much more accurate at predicting prognosis, but this finding needs to be verified by a larger multicentre study.

The investigators are also studying the patient journey, so the investigators can better understand patients' experiences and the impact that treatments have on their quality of life. The investigators wish to understand if improvements in the accuracy of prognosis from scans could change treatment decisions in future. The investigators will also compare the radiology scan prediction of prognostic factors by looking carefully at the tumour specimens.

Detailed Description

A Retrospective and Prospective Cohort study to improve the prognostic accuracy of preoperative staging in patients diagnosed with primary rectal cancer. The intervention is the training of radiologists to implement specialised MRI reporting using the TDV staging system.

The investigators will collect anonymized scans, clinical and histopathology data from all rectal cancer patients diagnosed in 2019. The central reviewing radiologist will stage the scans by a) mrTDV and b) mrTNM into poor and good prognosis categories. The investigators will compare survival outcomes from original reports as well as the two staging systems using Kaplan-Meier and Cox Proportional-Hazard methods.

The investigators will compare prospectively collected data before and after implementation of the consensus for identifying and treating high-risk and low-risk rectal cancers. The investigators will report on the comparisons of staging, histopathology, MDT treatment decisions, resource utilisation, how patients experienced information provided for shared decision making before and after the intervention changes and quality of life measures.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study Start: 2025-07-01
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-05-31
• Study Completion: 2031-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

1. Have a rectal cancer proven on biopsy or subsequent surgery
2. Sites able to submit anonymised MRI staging scans, pathology and imaging reports for central review
3. Aged 16 years or over

Exclusion Criteria

1. Have irresectable metastatic disease at time of initial staging
2. Undergoing palliative treatment for Rectal Cancer
3. Have a biopsy-proven rectal malignancy which is not adenocarcinoma
4. Are contraindicated for MRI staging

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Validate that mrTDV staging can predict prognosis more accurately than mrTNM.	1 and 5 years	Survival differences for mrTNM and mrTDV before and after intervention will be compared

Secondary Outcome Measures

Name	Time	Method
Assess the degree of agreement between radiologists using mrTDV method of staging rectal cancer vs mrTNM method of staging rectal cancer.	1 and 5 years	Compare percentage agreement between radiologists when the TNM system of staging (scoring tumour, nodes and metastases) versus when using TDV system of staging (scoring tumour deposits and extramural venous invasion) is used.
Compare percentage agreement when staging of tumours using mrTDV method of staging rectal cancer and TNM method of staging rectal cancer with respective histopathology staging for prognosis.	1 and 5 years	Compare agreement in prognostic accuracy between radiology and histopathology using when the TNM system of staging (scoring tumour, nodes and metastases) versus when using TDV system of staging (scoring tumour deposits and extramural venous invasion) is used.
Measure the introduction of mrTDV staging and its impact on MDT decision-making with regards to treatment decisions	1 and 5 years	Comparison of what and how many treatments are offered as MDT policy to patients before and after mrTDV intervention
Report changes in numbers of treatments offered following MRI-TDV staging intervention	6 months and 1 year	Comparison of treatments given before and after mrTDV intervention
Report differences in disease free survival outcomes for rectal cancers staged using mrTNM method of staging versus TDV method of staging	1 and 5 years	Comparison of numbers of patients with disease free survival before and after mrTDV intervention
Report differences in local recurrence rates for rectal cancers staged using mrTNM method of staging versus TDV method of staging	1 and 5 years	Comparison of numbers of patients with local recurrencebefore and after mrTDV intervention
Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging	6 months, 1 and 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 before and after adoption of mrTDV staging	6 months, 1 and 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'
Report differences in patient LARS scores before and after adoption of mrTDV staging	6 months, 1 and 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'
Report differences in patient shared decision making (SDM) before and after adoption of mrTDV staging	6 months, 1 and 5 years	Comparison of SM-Q9 scores before and after intervention. Answers are rated from 1 very poor to 7 excellent
Validate an educational programme for radiologists and MDTs to improve MRI reporting with TDV staging.	6 months and 1 year	Percentage agreement of radiologists prognostic accuracy using mrTNM method of staging versus mrTDV method of staging
Comparison of inpatient costs between patients before and after intervention	18 and 36 months	Comparison of relative percentage histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention
Comparison of total cost of outpatient visits between patients before and after intervention	18 and 30 months	Comparison of total cost of outpatient episodes based on individual pathways before and after intervention
Number of patients without disease and/or without stoma before and after intervention	18 and 30 months	DFS and stoma free survival in patients based on individual pathways before and after intervention
Assessment of novel and existing histopathological biomarkers to improve prognostic and predictive markers	6, 12, 18 months and 3, 5 years	Comparison of relative percentage histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention

Trial Locations

Locations (3)

Southampton General Hospital; 🇬🇧 Southampton, Hampshire, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom

Salisbury District Hospital; 🇬🇧 Salisbury, Wiltshire, United Kingdom