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APHRODITE – WIP

IRAS ID: 250957

Welcome to the APHRODITE websit

If you are taking part in the APHRODITE trial, we would like to say a huge thank you for your help in developing ways in which we can improve cancer treatments.

This website provides some useful information about the trial as follows:

  • Background – what early rectal cancer is and the standard treatment for it.
  • About Our Trial – summary of what the APHRODITE trial is about.
  • On the Trial – what will happen to you on the trial, including a diagram of the treatment schedule.
  • Documents – patient newsletters, Patient Information Sheet and Key Facts Sheet available for download.
  • Meet The Team – the team working on the trial.
  • Who is Responsible for the Data? – a link to who is responsible for the data on the trial.
  • Useful links – links to the funder website, Leeds Radiotherapy Research Group and the trial twitter page for healthcare professionals.
  • Useful information for healthcare professionals – ISRTCN and IRAS numbers, details and site specific newsletters.

Background

Patients with small rectal cancers (i.e., early back passage cancers) would normally have surgery to remove the whole rectum to treat their cancer. However, there are some patients who are not suitable for surgery or would prefer not to have surgery.

There can be multiple reasons for this. One reason is that surgery could be thought to be too risky due to other medical problems, increasing the risks of having surgery. Another reason could be that because the patient would have difficulty looking after a stoma (bowel bag) following surgery. Or it could simply be that the patient strongly prefers to explore other treatment options rather than surgery.

For these patients radiotherapy or ‘chemoradiotherapy’ can be used which just means that radiotherapy is given at the same time as chemotherapy. The radiotherapy is given over 5.5 weeks and can lead to the cancer disappearing in about one third of patients.

About Our Trial

The APHRODITE trial will explore the potential benefit of giving a higher radiotherapy dose over 5.5 weeks than is usually given. The aim is to see if this improves the chance of the cancer completely disappearing, while at the same time not causing too many extra side effects. In the future, this could lead to better treatment and improved quality of life.

On the Trial

Randomisation

Once you have consented to participate in the trial, you will be randomised into either the standard dose radiotherapy arm or the higher dose radiotherapy arm. You are twice as likely to be randomised into the higher dose radiotherapy arm than the standard dose radiotherapy arm.

Following randomisation you will follow the treatment schedule below.
APHRODITE trial schema

Treatment

Once you start the trial, we will treat your cancer with radiotherapy over 5.5 weeks (Monday to Friday, with your weekends free) and chemotherapy. The chemotherapy can either be in tablet form or injected directly into your vein. Alternatively, if your doctor does not feel that you are suitable to receive chemotherapy, then you may be treated with radiotherapy alone.

Questionnaires

At the beginning and end of your treatment, we would like you to complete 3 questionnaires on your quality of life. We would also like you to complete them on your follow up appointments at 3, 6, 9, 12 and 24 months. Your research nurse will provide the questionnaires for completion on the day of your visit. It would be helpful to us if these are completed in clinic before you see your doctor at your hospital visit, so please arrive a little earlier before your appointment to complete the questionnaires. Alternatively, the questionnaires can be completed after your appointment with your doctor. Once completed you can hand the questionnaires to the doctor or research nurse.

Monitoring

We will keep checking that you are okay during the trial and will carry out regular blood tests that check your full blood count, liver function and urea and electrolytes. We will also ask how well you are or if you are having any side effects during your treatment to monitor your progress.

Follow-up

We would like to continue to monitor your progress once your treatment has ended, so we will arrange a telephone appointment for you with your research nurse 2 weeks after you finish your radiotherapy. From then on you will have regular follow up appointments at the hospital with your doctor at 3, 6, 9, 12 and 24 months following the start of your treatment.

Documents

When available, you will receive newsletters from your local research teams to keep you updated with the latest information on the trial. You can also find all newsletters in pdf format in the links below, or if you prefer a hardcopy your nurse will be happy to provide you with one at your next hospital appointment. For more information about newsletters please ask your research nurse.

In addition to newsletters, we have also provided a link below to the Key Facts Sheet and Patient Information Sheet to read again if you so wish.

APHRODITE Patient Information Sheet
APHRODITE Key Facts Sheet

Meet the Team

Professor Simon Gollins

Consultant Clinical Oncologist

Co-Chief Investigator


Professor Gollins is a Consultant Clinical Oncologist. He was based at the North Wales Cancer Treatment Centre from 1998-2022 and was Clinical Director of Oncology for Betsi Cadwaladr University Health Board from 2010-2021. In this NHS practice he was responsible for regular outpatient clinics at the North Wales Cancer Treatment Centre and Wrexham Maelor Hospital. He is now based at Shrewsbury and Telford Hospital NHS Trust, where as a Clinical Oncologist he is responsible for treating patients with cancer with both radiotherapy and chemotherapy. His subspecialty interests are upper and lower gastrointestinal cancer.
Professor Gollins qualified in medicine in 1988 at the University of Oxford, where he also carried out 3 years of laboratory research for a Doctor of Philosophy degree (PhD). Following medical jobs in Bath and Birmingham he gained his Membership of the Royal College of Physicians in 1991.
His oncology training took place at the Christie Hospital Manchester where he gained his Fellowship of the Royal College of Radiologists in 1994 and at Velindre Hospital Cardiff where he was also a Consultant Clinical Oncologist prior to moving to North Wales.
Professor Gollins was a Consultant Clinical Oncologist based at the North Wales Cancer Treatment Centre from 1998-2022 and was Clinical Director of Oncology for Betsi Cadwaladr University Health Board from 2010-2021. In this NHS practice he was responsible for regular outpatient clinics at the North Wales Cancer Treatment Centre and Wrexham Maelor Hospital. As a Clinical Oncologist he was responsible for treating patients with cancer with both radiotherapy and chemotherapy and his subspecialty interests are upper and lower gastrointestinal cancer.
Professor Gollins has previously been North Wales Clinical Lead for the Wales Cancer Research Network, was appointed Honorary Professor at Bangor University in 2018 and was Chair of the Colorectal Group of the National Cancer Research Institute (NCRI) from 2017-2021.

Dr Ane Appelt

Radiotherapy Physicist and Associate Professor

Co-Chief Investigator



Ane Appelt is a clinical radiotherapy researcher, with a background in medical physics and oncology. She works part-time in the NHS, in the radiotherapy department at St James’s University Hospital, and part-time at University of Leeds, where she is an Associate Professor of Radiotherapy Physics. Her main research focus is on improving radiotherapy treatment for lower gastrointestinal cancers, especially minimizing long term treatment toxicity.

Ane has a background in physics, but has spent the last decade working on cancer research in clinical radiotherapy in the UK and Denmark. She has degrees from Durham and University of Southern Denmark, including a PhD in Oncology. She has trained as a medical physicist in multiple hospitals in Denmark, and is a registered clinical scientist in the UK. Additionally, she has held a postdoctoral position at Rigshospitalet, University of Copenhagen, with several long stays as visiting researcher at the University of Wisconsin, Madison, and the MD Anderson Cancer Center in Houston, Texas.

Dr Samantha Noutch

Senior Trial Manager

Clinical Trials Research Unit



Samantha Noutch is a senior clinical trial coordinator, with a background in early phase clinical trial project management. Samantha has experience in running clinical trials in a project management and site management setting for both the pharmaceutical industry and academic trials.

Samantha has a background in neuropsychopathology and biomedical science, specialising in pharmacology. She obtained her Ph.D. from the University of Bradford, England.

Who is Responsible for the Data

Privacy and Cookie Use Guide

Useful Information for healthcare professionals

ISRCTN number: 16158514
IRAS ID: 250957

Trial Delivery

The APHRODITE trial is sponsor by the University of Leeds and funded by Yorkshire Cancer Research. Trial Management and Delivery is by the Clinical Trials Research Unit at the University of Leeds.

Trial Twitter

There is an APHRODITE Twitter for healthcare professionals. This is accessible through the following link: https://twitter.com/aphrodite_trial

Site Newsletters

The site newsletter are linked below. For patient newsletters, please see the section above titled “Documents”.

Newsletter 1 February 2020
Newsletter 2 March 2020
Newsletter 3 December 2020
Newsletter 4 April 2021
Newsletter 5 July 2021
Newsletter 6 October 2021
Newsletter 7 January 2022
Newsletter 8 May 2022
Newsletter 9 August 2022
Newsletter 10 December 2022

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Trial Management and Delivery