Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of chemoradiotherapy and durvalumab for invasive bladder cancer (Radio)
This trial is looking at adding durvalumab to chemoradiotherapy for people with bladder cancer.
It is for people whose cancer has grown into the muscle wall. This is invasive bladder cancer.
More about this trial
You might have chemoradiotherapy to treat invasive bladder cancer. Chemoradiotherapy means having chemotherapy and radiotherapy treatment together. It is a standard treatment in the UK for invasive bladder cancer.
Doctors are looking for ways to improve treatment. In this trial they are looking at adding a drug called durvalumab to chemoradiotherapy. Durvalumab is an immunotherapy. It stimulates the body’s
The main aims of the trial are to:
- find out if adding durvalumab to chemoradiotherapy is safe
- find out if adding durvalumab to chemoradiotherapy improves treatment
- learn more about the side effects
- find out how treatment affects quality of life
Who can enter
The following bullet points list 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 this trial if all of the following apply.
adenocarcinoma, transitional cellcancer or squamous cell cancerthat has grown into the muscle wall of the bladder but no further
- are well enough to have high dose radiotherapy
- weigh more than 30 kg (4.7 stone)
- have satisfactory blood test results
- are well enough to carry out all your normal activities but you might not be able to do heavy physical work (performance status of 0 or 1)
- are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply.
- have cancer that has spread elsewhere in the body
- have had radiotherapy to the area between the hip bones (
pelvis) in the past
- have had both hips replaced making it difficult for the doctor to develop an accurate radiotherapy plan
- have had durvalumab or a similar drug in the past
- are having any other cancer treatment including chemotherapy,
targeted drugsand hormone therapy.
- have taken part in another clinical trial in the last 30 days or you are taking part in a trial unless it doesn’t involve treatment or you are in the follow up period
- have had a heart attack in the last 12 months or you have another heart problem such as angina that needs treatment
- have a serious problem with your lungs, kidneys or liver that need treatment
- have an active
autoimmune diseaseor immune condition that needed treatment in the 3 months before being put into a treatment group or you have a severe problem with either of these. This is apart from certain ones. Your doctor will know about this.
- have a serious problem with your
digestive systemthat causes diarrhoea
- have a lung condition called interstitial lung disease
- have a problem with your
bone marrowand it isn’t working properly after radiotherapy or chemotherapy
- have low levels of red blood cells, white blood cells and platelets or you have an increased risk of having a bleed
- have moderate to severe side effects from past treatments that aren’t getting better apart from hair loss or loss of skin colour (vitiligo)
- have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the last 2 weeks unless it was a very small dose, a cream, inhaler or injections into a joint
- take anti viral medications such as brivudine or sorivudin
- have inflammation of the lung called
- have a problem with your
immune systemand it doesn’t work properly
- have an active infection including tuberculosis (TB), chicken pox, hepatitis B or hepatitis C
- have had major surgery apart from an operation to remove the cancer from inside the bladder (a transurethral resection of a bladder tumour) in the 30 days before starting trial treatment
- have low levels of the DPD enzyme (DPD deficiency – this can make the side effects of certain chemotherapy drugs worse)
- are having treatment for another condition that may interfere with any of the treatments in the trial
- have any other medical condition or mental health problem that the trial team think would affect you taking part
- have had an
- have had a live
vaccination.This doesn't include the approved COVID-19 vaccines as these aren't live.
- are pregnant or breastfeeding
- are allergic or sensitive to any of the trial treatments or anything they contain
This is a phase 2/3 trial.
The earlier part of this trial was randomised. People were put into treatment groups by a computer. They had one of the following:
- chemoradiotherapy and durvalumab
This part is now closed. Everyone who joins this trial now has chemoradiotherapy and durvalumab. The team need 52 people in the UK to have chemoradiotherapy and durvalumab.
Chemoradiotherapy and durvalumab
Before you begin treatment, the radiotherapy team works out how much radiation you need. This is called a radiotherapy planning session. This takes about an hour and a half.
You have durvalumab as a drip into a vein. You start it one week before you begin chemoradiotherapy. You have it once every 4 weeks for up to 1 year. It takes about 2 hours each time.
You have radiotherapy Monday to Friday for 4 weeks. You have radiotherapy to the whole bladder. Each treatment takes about 15 minutes.
You have 1 treatment with mitomycin C on day 1. This is on the same day you start radiotherapy. You have mitomycin C as a drip into a vein. This takes about an hour.
You have fluorouracil (5FU) on:
- day 1 of week 2
- day 1 of week 4
You have it as a slow drip via a small pump. You can keep the pump in a small bag, or on a belt (like a bum bag). You have the 5FU continuously for 5 days. The team arrange to have it disconnected when it is finished.
Quality of life
The trial team ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
The trial team send the questionnaires to you. You complete them and return them in the prepaid envelopes.
Samples for research
Some hospitals are taking part in some extra research looking at blood and urine samples. If you agree to take part the team ask to take:
- extra blood tests
- urine samples
Researchers plan to look for
The trial team ask to use a sample of tissue your doctor took when you had surgery or a biopsy (
The team can let you know more about these studies if you’d like to join.
You see a doctor and have some tests before you join the trial. These include:
- blood tests
- urine tests
- heart trace (
- a test to look inside your bladder (a cystoscopy)
- CT scan or MRI scan
During chemoradiotherapy you see the doctor every week for blood tests and a check up. You then see the team once a month for a check up when you finish chemoradiotherapy.
After you finish chemoradiotherapy you have a CT scan or MRI scan and a cystoscope at:
- 3 months
- 6 months
- 12 months
You see the team 1 month after finishing trial treatment.
A year after you finish chemoradiotherapy you see the doctor for a check up every 3 months for at least 2 years.
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.
Durvalumab can affect the
These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.
The most common side effects of durvalumab are:
- coughs, colds or a sore throat (an upper respiratory tract infection)
- tummy (abdominal) pain
- low levels of the thyroid hormone which may cause symptoms such as tiredness, constipation or increased sensitivity to cold
- skin rash or dry and itchy skin
- high temperatures (fever)
Some people having the combination of durvalumab and chemotherapy have extra side effects. The most common include:
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- loss of appetite
- hair loss
- feeling or being sick
- tiredness (fatigue)
The most common side effects of radiotherapy include:
- diarrhoea or constipation
- discomfort around the back passage (rectum)
- opening your bowels more often
- pain when opening your bowels or passing urine
- inflammation of the bladder causing you to feel you need to pass urine more often
- loss of appetite and weight loss
We have information about the side effects of:
How to join a clinical trial
Professor Nicholas James
University of Birmingham