1 / 6

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)

markjenkins
Télécharger la présentation

Introduction

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

  6. Version 4.0 01-JUN-2018 Slide 16 of 96

More Related