A Phase II trial of Higher RadiOtherapy Dose In The Eradication of early rectal cancer

IRAS ID: 250957

Hello and thank you for taking the time to visit the APHRODITE website. Here you will find useful information about the APHRODITE trial.

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

We will post a new APHRODITE newsletter to the website every 6 months to keep you updated with the latest information on the trial. Alternatively, if you prefer a hardcopy your nurse will be happy to provide you with one at your next hospital appointment. We have also provided you a link to the Key Facts sheet and Patient Information Sheet to read again if you so wish.

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Background

Some patients with rectal cancer are not able to have it removed by surgery. They may suffer from symptoms as their cancer grows, including pain, diarrhoea and the need for a stoma (bowel bag). For these patients, radiotherapy combined with chemotherapy is used. A standard dose of radiotherapy given over 5.5 weeks can lead to the cancer disappearing in about one third of patients. We want to find out if a higher radiotherapy dose given over the same time will give greater benefit to patients with acceptable side effects. This could lead to better treatment and improved quality of life.

Our Study

Patients with small (early) rectal (back passage) cancers would normally have these treated using surgery to remove the whole rectum. However, there are some patients who are not suitable for surgery. This can either be because surgery is thought to be too risky because of other medical problems which would increase the risks of having surgery. Or it can be because patients would have difficulty looking after a stoma (bowel bag) following surgery. For such patients, radiotherapy or radiotherapy given at the same time as chemotherapy (‘chemoradiotherapy’) can be used. A standard dose of radiotherapy is given over 5.5 weeks and can lead to the cancer disappearing in about one third of patients.

The APHRODITE study will explore the potential benefit of giving a higher radiotherapy dose over 5.5 weeks 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.

Trial Schema

After randomisation into either the standard dose radiotherapy arm or the higher dose radiotherapy arm, you will follow the treatment schedule below:

APHRODITE trial schema

On the study

  • Once you start the study, we will treat your cancer with radiotherapy over 5 1/2 weeks (Monday to Friday, with your weekends free) and chemotherapy. The latter 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.
  • 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.
  • We will keep checking that you are OK during the study 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.

On the study

  • 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.

Meet the Team

Professor Simon Gollins
Consultant Clinical Oncologist
Co-Chief Investigator

Professor Simon Gollins is a Consultant Clinical Oncologist based at The North Wales Cancer Treatment Centre, Glan Clwyd. 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 has been a Consultant Clinical Oncologist based at the North Wales Cancer Treatment Centre since June 1998 and has been Clinical Director of Oncology for Betsi Cadwaladr University Health Board since 2010. In his NHS practice he is responsible for regular outpatient clinics at the North Wales Cancer Treatment Centre and Wrexham Maelor Hospital. As a Clinical Oncologist he is responsible for treating patients with cancer with both radiotherapy and chemotherapy and his subspecialty interests are upper and lower gastrointestinal cancer, pancreaticobiliary cancer, head and neck cancer and thyroid cancer.

Since 2005 Professor Gollins has been North Wales Clinical Lead for the Wales Cancer Research Network and in 2008 he became a Member of the Colorectal Clinical Studies Group of the National Cancer Research Institute (NCRI) and in October 2013 was appointed Visiting Professor at Glyndwr University.
Dr Ane Appelt
Physicist and YCR University Academic Fellow
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 holds a Yorkshire Cancer Research Fellowship. 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 Coordinator
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.

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