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Introduction

Introduction. Funders: Cancer Research UK (CRUK) Sponsor : University of Birmingham Chief Investigator: Mr Simon Bach (UHB, Queen Elizabeth Hospital) Co-Chief Investigator: Prof David Sebag -Montefiore (St James's University Hospital, Leeds)

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Introduction

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  1. Introduction • Funders: Cancer Research UK (CRUK) • Sponsor: University of Birmingham • Chief Investigator: Mr Simon Bach (UHB, Queen Elizabeth Hospital) • Co-Chief Investigator: Prof David Sebag-Montefiore (St James's University Hospital, Leeds) • Coordinating Centre: Birmingham Clinical Trials Unit (BCTU) Contact Details: Chief Investigator: Mr Simon Bach Co-Chief Investigator: Prof David Sebag-Montefiore E-mail: s.p.bach@bham.ac.uk E-mail: d.sebagmontefiore@leeds.ac.uk STAR-TREC Trial Office contact details: Trial Manager: MrsManjinder Kaur Address: STAR-TREC Trial Office, E-mail: m.kaur@bham.ac.uk Birmingham Clinical Trials Unit (BCTU), E-mail: STAR-TREC@trials.bham.ac.uk Institute of Applied Health Research, College of Medical and Dental Sciences Tel: 0121 415 9105 Public Health Building Fax: 0121 415 8871 University of Birmingham Edgbaston, Birmingham B15 2TT Version 4.0 01-JUN-2018 Slide 3 of 96

  2. Scientific Background and Rationale: • Increasing incidence of early rectal cancer poses new surgical dilemma • Introduction of the bowel screening programme in 2006 changed how rectal cancer presents • Current standard care for early stage rectal cancer = Total mesorectal excision (TME) surgery • Low Anterior resection • Abdominoperineal resection • High rates of cure • Only 2% and 12% of patients experience local or distant failure respectively • Post-operative morbidity • Permanent stoma in approximately 5-10% of cases • Three prospective cohort studies have examined health related quality of life scores following rectal cancer. Each demonstrated persistently poor social, role, body image and defaecation scores. • Concerns that radical surgery, may not be the optimal method of treatment for early screen-detected tumours. • An organ preserving strategy may generate significantly less morbidity without substantially compromising oncological outcomes. Version 4.0 01-JUN-2018 Slide 6 of 96

  3. Trial Design and Aims • Trial Schema • Design: Randomised feasibility study • Primary Aim: Accelerate recruitment from 2 patients per month to 6 per month over a 2 year period • Target Recruitment: 120 patients overall, 60 from the UK • Duration: • Two year recruitment • Three year follow-up Version 4.0 01-JUN-2018 Slide 11 of 96

  4. Inclusion criteria • Biopsy proven adenocarcinoma • MRI T1-3b N0 M0 • MDT agrees patient suitable for: (a) TME surgery (b) CRT (c) SCPRT and (d) TEM • Negative pregnancy test • 16+ in UK • 18+ in Netherlands and Denmark • Able and willing to provide informed consent Version 4.0 01-JUN-2018 Slide 14 of 96

  5. Exclusion Criteria • On MRI: • Node positive • Extramural vascular invasion present • Defined mucinous tumour • Mesorectal fascia threatened (< 1 mm on MRI) • Maximum tumour diameter > 40mm • Anterior tumour location above the peritoneal reflection on MRI or ERUS • No residual luminal tumour following endoscopic mucosal resection • Prior pelvic radiotherapy • Regional or distant metastases • Patients with previous colon cancer or previous malignancy are not an exclusion. Version 4.0 01-JUN-2018 Slide 15 of 96

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