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Rectal Diseases

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.

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.

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.

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.

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.

Surveillance 6 monthly

Radiotherapy and surveillance

surveillance 3 montly

Gina Brown

Xian van Gelder

This multicentre, prospective, randomised, feasibility trial aims to change UK practice by enabling more patients with early rectal cancer to safely undergo local excision rather than major surgery thus maintaining quality of life without compromising survival outcomes.

The national bowel cancer screening programme (BCSP) has shown an increase in detection rates of early rectal cancer (ERC). This is treated effectively with radical surgery, offering excellent oncological outcome, but has a major impact on patient quality of life. The diagnosis of early stage rectal cancer, allows an opportunity for effective oncological treatment, with preservation of the rectum avoiding the deleterious effects of unselective use of radical surgery and unselected use of radiotherapy. Our previous work has led to High-Spatial-Resolution magnetic resonance imaging (MRI) as the established modality for providing reliable information about extramural disease prior to radical surgery.

This trial will use a new MRI staging protocol to identify more patients with early rectal cancer to enable accurate mapping for more precise patient selection for local excision. Improved success with local excision will result in greater rates of organ preservation.

Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.

Demonstrate a change in rectal preservation rates in patients with pT1 and pT2 tumours.

To measure the accuracy of MRI T staging when compared with pathology.

Report on rates of missed lesions suitable for local excision.

Report on rates of lesions not feasible for local excision

Compare costs to the NHS/other healthcare systems of major surgery versus local excision for pT1/T2 ERC.

Measure impacts of local excision and rectal preservation on patient reported quality of life outcome measures compared with stage matched patients undergoing major surgery due to patient choice or technical inability to undertake locale scission. Measurement tools used for assessment are the LARS (low anterior resection syndrome) score, the EQ-5D and Stoma Care Quality of Life Questionnaire.

Put in a separate point saying: Measure survival rates at 1 year post surgery / local excision.

To assess the quality of local excision surgery, using review of pathology slides and reports, commenting on completeness of excision, excision margins and en bloc manner of resection (local excision specimens).

Assess patient willingness to be randomised by qualitative questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.	NCT04103372	Rectal Cancer	Surveillance 6 ... Radiotherapy an... surveillance 3 ...	18 Years -	Royal Marsden NHS Foundation Trust
Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.	NCT04103372	Rectal Cancer	Surveillance 6 ... Radiotherapy an... surveillance 3 ...	18 Years -	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for surveillance 3 montly