Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A study looking at an increased dose of intensity modulated radiotherapy to treat head and neck cancer (ArChIMEDEs-Op)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at an increased dose of intensity modulated radiotherapy (IMRT) to treat cancer where the mouth joins the throat (the oropharynx). Doctors call this oropharyngeal cancer. This study is for people whose oropharyngeal cancer is not linked to the
Doctors can treat oropharyngeal cancer with a combination of chemotherapy and radiotherapy (
The aim of this study is to see if it is safe and possible to give a 5 week course of radiotherapy at an increased dose with standard dose chemotherapy to treat oropharyngeal cancer that is HPV negative.
Who can enter
You may be able to enter this study if
- You have cancer where your mouth joins your throat (oropharyngeal cancer) that is of the most common type called squamous cell
- Your cancer has grown into surrounding tissues or spread to nearby
lymph nodes(it is locally advanced)
- Your cancer is negative for the HPV virus and a protein called P16 – the researchers will test for this
- You are having chemoradiation with the aim of curing your cancer and are having radiotherapy to both sides of your neck
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
- You are between 18 and 75 years old
You cannot enter this trial if you
- Have already had radiotherapy to your head and neck
- Are only having radiotherapy to 1 side of your neck
- Have had a heart attack in the past 6 months or any other serious heart problem
- Have had another cancer in the past 3 years apart from basal cell skin cancer and in situ carcinoma of the cervix
- Have any other medical condition that could affect you taking part in this study
- Are pregnant or breast feeding
This is a feasibility study. It will recruit 15 people who are having treatment at the University Hospitals Birmingham NHS Foundation Trust.
Everyone has radiotherapy for 5 weeks (Monday to Friday).
If your doctor thinks you are unable to have cisplatin, they will give you another chemotherapy drug called carboplatin. You have carboplatin as a drip into a vein.
As a part of planning your radiotherapy, you will have a special plastic mask made to wear during your radiotherapy. This is to make sure that the radiotherapy is aimed accurately each time.
You see the doctor to have some tests before taking part in this study. These tests usually include
Your doctor will also ask you about what you eat.
Every week during radiotherapy your doctor will see you to find out about any side effects you are having from the radiotherapy. You also see a
After radiotherapy you see the doctor
- Weekly for 2 months
- 3 monthly to 1 year
- 6 monthly to 2 years
- Yearly to 5 years
The most common short term side effects of radiotherapy to the head and neck are
- Sore mouth and throat due to ulceration
- Difficulty swallowing
- Change of taste
- Sticky secretions
- Sore skin in the area being treated
- Tiredness (fatigue)
The most common side effects of cisplatin are
- Feeling or being sick (nausea)
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Numbness or tingling in your hands or feet
- Changes to your hearing
- Changes to taste and loss of appetite
Your doctor will talk to you about the possible side effects of treatment.
We have more information about side effects of radiotherapy to the head and neck in our head and neck radiotherapy side effects section. We also have more information about cisplatin in our cancer drugs section.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Paul Sanghera
Queen Elizabeth Hospital Birmingham Charities
University Hospital Birmingham NHS Foundation Trust