1. The STAR-TREC Trial SIV Presentation
Introduction
26-JUN-2018
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
STAR-TREC Trial Office contact details:
Trial Manager: Mrs Manjinder Kaur Address: STAR-TREC Trial Office,
Birmingham Clinical Trials Unit (BCTU),
Institute of Applied Health Research,
College of Medical and Dental Sciences
Tel: Public Health Building
Fax: University of Birmingham
Edgbaston, Birmingham
B15 2TT
Version JUN-2018
Slide 3 of 96
Version JUN-2018

2. Scientific Background and Rationale:
The STAR-TREC Trial SIV Presentation
26-JUN-2018
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.
Colorectal cancer is the third most common tumour in the UK, Netherlands and Denmark.
with 41000, and 4000 new cases per year respectively.
Approximately one-third of these are rectal cancers.
In the UK, introduction of the NHS Bowel Screening Program (NBSP) from 2006 is changing how rectal cancer presents.
The major benefit of screening is increased early detection; over 50% of screen-detected rectal cancers are early stage and limited within the bowel wall.
By 2009 the proportion of early stage rectal cancer diagnosed in the UK had risen from 8 to 25%.1, 2 With the Netherlands and Denmark commencing screening in 2014, similar increases in early rectal cancer incidence are expected.
Version JUN-2018
Slide 6 of 96
Version JUN-2018

3. The STAR-TREC Trial SIV Presentation
26-JUN-2018
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 JUN-2018
Slide 11 of 96
Version JUN-2018

4. The STAR-TREC Trial SIV Presentation
26-JUN-2018
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 JUN-2018
Slide 14 of 96
Version JUN-2018

5. The STAR-TREC Trial SIV Presentation
26-JUN-2018
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 JUN-2018
Slide 15 of 96
Version JUN-2018

6. Version JUN-2018
Slide 16 of 96