Improving Diagnosis and Treatment for Patients With Rectal Cancer

Official title

Improving the Prognostic Accuracy of Staging Rectal Cancer Using Magnetic Resonance Imaging (MRI) - Detected Tumour Deposits and Vascular Invasion (mrTDV) Instead of Tumour Nodal Metastasis (mrTNM)

Overview

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.

Interventions

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

Primary outcome measures

• Validate that mrTDV staging can predict prognosis more accurately than mrTNM. [Time frame: 1 and 5 years]

Secondary outcome measures (12)

• Assess the degree of agreement between radiologists using mrTDV method of staging rectal cancer vs mrTNM method of staging rectal cancer. [Time frame: 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. [Time frame: 1 and 5 years]
• Measure the introduction of mrTDV staging and its impact on MDT decision-making with regards to treatment decisions [Time frame: 1 and 5 years]
• Report changes in numbers of treatments offered following MRI-TDV staging intervention [Time frame: 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 [Time frame: 1 and 5 years]
• Report differences in local recurrence rates for rectal cancers staged using mrTNM method of staging versus TDV method of staging [Time frame: 1 and 5 years]
• Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging [Time frame: 6 months, 1 and 5 years]
• Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging [Time frame: 6 months, 1 and 5 years]
• Report differences in patient LARS scores before and after adoption of mrTDV staging [Time frame: 6 months, 1 and 5 years]
• Report differences in patient shared decision making (SDM) before and after adoption of mrTDV staging [Time frame: 6 months, 1 and 5 years]
• Validate an educational programme for radiologists and MDTs to improve MRI reporting with TDV staging. [Time frame: 6 months and 1 year]
• Comparison of inpatient costs between patients before and after intervention [Time frame: 18 and 36 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Crossover

Masking

Open label

Primary purpose

Diagnostic

Study locations

United Kingdom · 3 centers

• Southampton General Hospital — Southampton
• John Radcliffe Hospital — Oxford
• Salisbury District Hospital — Salisbury

Publications

• 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
• 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
• 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
• 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 PMID 35512720

Identifiers

NCT: NCT07054047 · EDGE: 176847 · 348532 · 25/EM/0105

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗