A trial of radiotherapy and targeted treatment for head and neck cancer (ADePT-DDR)
Cancer type:
Status:
Phase:
This trial is looking at adding certain targeted drugs to radiotherapy for head and neck cancer. Some parts of the trial are also looking at these treatments with 
The trial is for people who have one of the following types of head and neck cancer:
- mouth and oropharyngeal cancer
- cancer of the area that surrounds the voice box (
hypopharynx - cancer of the voice box (laryngeal cancer)
More about this trial
A combination of radiotherapy and chemotherapy is a usual treatment for people with squamous cell cancer of the head and neck. This is called chemoradiotherapy. This isn’t suitable for everyone so you may have only radiotherapy.
Radiotherapy works by damaging the inside cancer cells, which could cause them to die. Certain drugs work by stopping cells from repairing damage to their DNA. These drugs are called DNA damage response inhibitors (DDRi). They make it more likely that a damaged cell will die. Researchers think that having a DDRi drug with radiotherapy might improve treatment.
In this trial doctors are looking at different DDRi’s. The only part of this trial that is open at the moment is looking at a drug called ceralasertib. It is a type of DDRi.
The main aims of the trial are to find out:
- the best dose of ceralasertib to have alongside radiotherapy
- more about the side effects of the combination of treatment
- how treatment affects quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join part one of this trial if you have one of the following types of head and neck cancer:
- mouth and oropharyngeal cancer
- cancer of the area that surrounds the voice box (
hypopharynx - cancer of the voice box (laryngeal cancer)
As well as the above, you may be able to join this trial if all of the following apply. You:
- have
squamous cell cancer of the head and neck - have cancer that is 2cm or larger and has spread to the
lymph nodes - are due to have radiotherapy to treat your cancer
- have cancer that your doctor can see on a scan
- you are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
- have satisfactory blood test results
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join part one of this trial if any of these apply. You:
- have already had treatment for head and neck cancer
- have had chemotherapy,
hormone treatment or a targeted drug within 21 days of starting treatment in this trial. You cannot join the trial if you have had an immunotherapy in the last 42 days. - have a condition called ataxia telangiectasia or any other condition that means you can’t have radiotherapy. Your doctor will know this.
- have moderate to bad side effects from past treatment. You can join if you have hair loss or moderate numbness and tingling in your hands or feet (
peripheral neuropathy )
Medical conditions
You cannot join this trial if any of these apply. You:
- have or have had a heart attack or a significant
heart problem that needed treatment in the last 6 months. The trial team check if you have a heart condition before you join the trial. - have a bleeding problem
- have had a kidney transplant or have kidney problems
- have fits (seizures)
- have a severe breathing problem or lung disease
- have severe Parkinson’s disease
- have inflammatory bowel disease such as ulcerative colitis or Crohn's disease.
- have an active hepatitis B or hepatitis C infection, HIV or any other infection that needs treatment
- have a problem with your
digestive system - are taking medication or herbal supplements that affect the CYP enzymes
- have any other medical condition or mental health problem that the trial team think would affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic to ceralasertib or anything it contains
- are pregnant or breastfeeding
Trial design
This trial is taking place in the UK. The part of the trial that is open is the phase 1 part.
The trial team plan to open more treatment groups looking at different DNA damage response inhibitors (DDRi). We will update the summary when these treatment groups open.
Treatment part 1 (open for people to join)
There are 2 groups. You and your doctor discuss which group you will join:
- 20 people have radiotherapy only (
control group ) - 60 people have radiotherapy and ceralasertib
Radiotherapy only group
You have radiotherapy everyday Monday to Friday. You have a break at the weekend. You have radiotherapy for 7 weeks. Each treatment takes about 10 to 20 minutes. This is .
Radiotherapy and ceralasertib group
You have radiotherapy as described above. You also take ceralasertib. It is a tablet. The dose you have and how long you have it for depends on when you join the trial.
The first few people taking part have a low dose of ceralasertib. The next few people have a higher dose if they don’t have any serious side effects. And so on until they find the best dose to give. Your trial doctor or nurse will tell you the number of tablets to take and when to take them.
Samples for research
The trial team ask you to give some extra blood samples. Where possible you have these at the same time as your routine blood tests.
They will also ask to look at samples of the cancer from when you had surgery or gave a sample of cancer tissue ().
The researchers plan to use the samples to:
- look at substances called
biomarkers to help work out why treatment might work for some people and not for others - look at
genes in your cancer cells to learn more about head and neck cancer - see what happens to ceralasertib in the body
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- at set times during and after treatment
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Patient diary
You have a patient diary to write down:
- when you take your tablets
- any other medication you have taken
- any side effects
Hospital visits
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Only a small number of people have had ceralasertib. So there may be side effects we don’t know about yet.
The most common side effects of ceralasertib we know about so far include:
- a drop in the number of blood cells causing an increased risk of infection, bruising and bleeding, tiredness and breathlessness
- tiredness (fatigue)
- feeling sick
Ceralasertib might make some of the side effects of radiotherapy worse. For example skin soreness or problems swallowing due to mouth ulcers. The trial team and radiotherapists keep a close eye on this.
The team will talk to you about all the possible side effects of treatment before you join the trial.
We have information about :
- the side effects of radiotherapy
- radiotherapy for mouth and oropharyngeal cancer
- radiotherapy for laryngeal cancer
Please note
You cannot have grapefruit juice or Seville oranges while you are taking ceralasertib.
Ceralasertib might make you more sensitive to sunlight. You must avoid spending long periods of time in the sun. If you are out in the sun, you will need to wear sunglasses and use a sunscreen that is at least factor 30 (SPF 30). You mustn’t use tanning booths during the trial.
Location
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Anthony Kong
Supported by
AstraZeneca
University of Birmingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
