Colorectal Current Research

The STAR-TREC study aims to find the best way of treating a small rectal cancer when it is detected at an early stage and specifically if it is possible to treat this condition without removing the whole rectum. To do this we will compare three different approaches.   

Standard treatment involves a major operation to remove the whole rectum. We call this approach radical surgery. There are two new approaches to tackle the disease designed to avoid radical surgery and preserve the rectum. These are called organ preservation treatments, and they are only offered to patients within the STAR-TREC study. These new treatment options use different types of radiotherapy to try and shrink the cancer as much as possible.  

This study will compare the two different organ preserving treatments to find out which method works best to preserve the rectum. The study will also compare their complications and side effects. We also want to investigate how each treatment affects patients’ quality of life and bowel function, by asking you to complete specially designed forms before, during and after your treatment. Finally, we want to compare these new organ preserving treatments against standard surgery.

Principal Investigator: Ann Lyons

Planned End Date: 31/12/2023

Local Ref (R&D no): 3870

Background: Cancer is a global problem. There is significant pre-clinical and epidemiological evidence demonstrating that aspirin has anti-cancer effects. Recently, individual patient data meta-analyses, from trials designed to assess cardiovascular benefits of aspirin, have shown reductions in cancer incidence and mortality associated with regular aspirin use. Additionally, the CAPP2 trial has demonstrated that daily aspirin prevents cancers associated with the Lynch syndrome.

In the meta-analyses, short-term effects on cancer mortality and a decrease in risk of metastases suggest a role for aspirin in the treatment as well as prevention of cancer. This is supported by several large observational datasets. Concerns over toxicity, particularly serious haemorrhage, have limited the use of aspirin in the primary prevention of cancer. In the adjuvant setting the benefit:risk ratio will be different, with higher morbidity and mortality from recurrent cancer potentially outweighing risks associated with regular aspirin use.

Aim: To assess whether regular aspirin use after standard therapy prevents recurrence and prolongs survival in patients with early stage common solid tumours. International recruitment will allow assessment of the intervention in different communities.

Methods: The question will be addressed in four tumour sites (colorectal, breast, gastrooesophageal, prostate) using parallel trials with a common infrastructure. Each trial will be a multicentre, phase III, double-blind, placebo-controlled randomised trial. Participants will be randomised to 100mg aspirin, 300mg aspirin or a matching placebo, to be taken daily for 5 years.

Primary outcomes will depend on tumour site and trials will be separately powered, requiring 2000-3000 patients with each tumour type to demonstrate effects of aspirin on disease recurrence and survival. Secondary outcomes include overall survival, adherence, gastrointestinal complications and cardiovascular events.

Project Details
Principal Investigator: Ms Ann Lyons
Planned End Date: 02/05/2027
Local Ref: 3589

Bacteria live in the intestine to help digest food. If the intestine is damaged by an operation, injury or a disease such as cancer, bacteria can leak into the space surrounding the intestine (called the abdominal cavity) and cause a serious “intra-abdominal infection.” The usual treatment for this is a course of antibiotics (usually for 7 – 18days) and sometimes surgery too. But unfortunately, these infections are complicated and the treatment doesn’t always work. In 50% of patients the infection will return, or they will develop a new one further down the line. This is called “treatment failure” and requires another course of antibiotics, and possibly more surgery.

However, current research suggests that a longer course of antibiotics may benefit these patients by preventing treatment failure and further hospital admissions. So, the EXTEND trial will be comparing an extended course of antibiotics (28 days) against the normal duration of antibiotics (7 – 18 days). Each participant will be allocated by chance into one of these two groups and will be closely monitored for the next 6 months to see if the extended course of antibiotics offers a benefit to patients by reducing the rate of treatment failure.

Principal Investigator: Anne Pullybank

Planned End Date: 30/06/2025

Local Ref (R&D no): 5187

REINFORCE aims to evaluate surgical services within the NHS, in order to determine the best ways to perform surgery. We will be collecting data on all specified surgeries at participating hospitals for the duration of the study (2 years). We will look at outcomes from patients, surgeons, theatre staff, and the wider organisation (NHS). We hope that when completed, we can advise the NHS on how best to provide their surgical services. 

Principal Investigator: Mr Andy Smith

Planned End Date: Recruitment duration 24 months. 10/01/2025

Local Ref (R&D no): 1278

People having short stay surgery (who either go home the same day or who stay overnight but go home shortly afterwards) are at a much lower risk of developing a blood clot than those who stay in hospital for longer. These low-risk people are often given elastic stockings (which squeeze the leg muscles) to reduce the chance of a blood clot. The risks of wearing the stockings are low but they can be uncomfortable. In the UK, there are over a million short stay surgeries performed each year and most of these people are given elastic stockings to wear. Stockings cost the NHS a lot of money and it remains unknown if they benefit these people. 

This study will investigate if it is worthwhile to continue using elastic stockings in people having surgery where the risk of developing blood clots is low.

Principal Investigator: Mr James Hopkins

Planned End Date: 31/12/2025

Local Ref (R&D no): 5200

The study aims to further medical knowledge and may improve future treatment of melanoma. The study will investigate how much skin should be removed from around the melanoma during wider excision surgery. Currently, doctors do not know how much skin to remove from around a melanoma to reduce the chances of it coming back. Guidelines in different countries vary in their recommendations on this. This study will investigate if reducing the excision margin to 1cm is as good at reducing the risk of melanoma returning as a 2cm excision margin.

Principal Investigator: Mr Ewan Wilson

Planned End Date: 01/07/2029

Recruitment to end 01/07/2025

Local Ref (R&D no): 4755