Improving Diagnosis and Treatment for Patients With Rectal Cancer

NCT07054047 | Not Yet Recruiting

• 3 other identifiers: EDGE: 17684734853225/EM/0105
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 3

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.

Conditions

GI Cancer

Keywords

Shared decision making; Radiotherapy; Quality of Life; MRI Staging; MDT Decision Making; Histopathological Staging; Rectal Cancer; Preoperative staging

Outcome Measures

Primary Outcomes (1)

• Validate that mrTDV staging can predict prognosis more accurately than mrTNM.

  Survival differences for mrTNM and mrTDV before and after intervention will be compared

  1 and 5 years

Secondary Outcomes (15)

• 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 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

• Measure the introduction of mrTDV staging and its impact on MDT decision-making with regards to treatment decisions

  1 and 5 years

• Report changes in numbers of treatments offered following MRI-TDV staging intervention

  6 months and 1 year

• 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

Study Arms (3)

Control Arm Schedule

NO INTERVENTION

All sites will begin in the Control arm, with patients recruited to the Control Arm Schedule. Clinical investigations prior to treatment, during treatment, after surgery and during further treatment should be performed as per standard clinical practice and as clinically indicated. Each site will remain in the Control Arm Schedule for six months. There will be a transition month with no recruitment where training is undertaken. After the transition month patients are recruited to the Intervention Arm Schedule . Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point.

Intervention Arm Schedule

EXPERIMENTAL

During the transition month, all Radiologists involved in reporting rectal cancers for the MDT will be offered training in reporting of mrTDV. Results of the retrospective data analysis will be shared at the MDT teams stakeholder meeting to determine their optimum stage based preoperative treatment decision making policy. Every site will remain in the Intervention Arm Schedule for six months. Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point.

Other: mrTDV

Retrospective cohort

NO INTERVENTION

Registration of all rectal cancer patients staged as non-metastatic in their site pre-treatment MDT from 1st January 2019 - 31st December 2019 should commence as soon as the site is issued the green light. The analysis of this data will be presented to their site MDT six months from the green light. Therefore, every effort should be made to complete the 2019 retrospective cohort registrations within the first three months of the trial start. We anticipate the average number of 2019 retrospective cohort patients treated for rectal cancer will be 20 per site.

Interventions

mrTDV OTHER

The training of radiologists to implement specialised MRI reporting using the TDV staging system

Intervention Arm Schedule

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• NHS England: collaborator
• Pelican Cancer Foundation: collaborator

Study Sites (3)

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Salisbury District Hospital

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

Location

Related Publications (4)

• Morris EJA, Finan PJ, Spencer K, Geh I, Crellin A, Quirke P, Thomas JD, Lawton S, Adams R, Sebag-Montefiore D. Wide Variation in the Use of Radiotherapy in the Management of Surgically Treated Rectal Cancer Across the English National Health Service. Clin Oncol (R Coll Radiol). 2016 Aug;28(8):522-531. doi: 10.1016/j.clon.2016.02.002. Epub 2016 Feb 28.

  PMID: 26936609 BACKGROUND

• Wilkinson E. NICE withdraws quality standard on colorectal cancer treatment after "lack of consensus". Lancet Oncol. 2022 Mar;23(3):333. doi: 10.1016/S1470-2045(22)00084-5. Epub 2022 Feb 10. No abstract available.

  PMID: 35151414 BACKGROUND

• Lord AC, D'Souza N, Shaw A, Rokan Z, Moran B, Abulafi M, Rasheed S, Chandramohan A, Corr A, Chau I, Brown G. MRI-Diagnosed Tumor Deposits and EMVI Status Have Superior Prognostic Accuracy to Current Clinical TNM Staging in Rectal Cancer. Ann Surg. 2022 Aug 1;276(2):334-344. doi: 10.1097/SLA.0000000000004499. Epub 2020 Sep 15.

  PMID: 32941279 BACKGROUND

• Lord AC, Corr A, Chandramohan A, Hodges N, Pring E, Airo-Farulla C, Moran B, Jenkins JT, Di Fabio F, Brown G. Assessment of the 2020 NICE criteria for preoperative radiotherapy in patients with rectal cancer treated by surgery alone in comparison with proven MRI prognostic factors: a retrospective cohort study. Lancet Oncol. 2022 Jun;23(6):793-801. doi: 10.1016/S1470-2045(22)00214-5. Epub 2022 May 2.

  PMID: 35512720 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases

Study Officials

• Gina Brown, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Martin

CONTACT

+44 (0) 7749 655 817; giclinicaltrials@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will proceed through three phases: pre-intervention, intervention, and post-implementation. Pre-intervention - local MDT decisions based on current MRI reporting practices will be collected for six months. Intervention - local radiologists will be trained to recognize features of mrTDV and use a standardised reporting template. We will present the retrospective and radiologists' cohort results to MDT stakeholders who will agree the optimum stage based preoperative treatment decision making policy. We will offer training as required using the 2019 retrospective cohort. Post-intervention - local MDT decisions based on the consensus optimum stage based preoperative decision-making policy will be collected for six months.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2031
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)