
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
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.
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 to fight cancer cells.
In this trial some people have chemoradiotherapy. And some have chemoradiotherapy and durvalumab.
The main aims of the trial are to:
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.
You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You
This is a phase 2/3 trial. The team need 159 people in the UK to take part.
It is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
You have 1 of the following:
Chemoradiotherapy group
Before you begin treatment, the radiotherapy team work out how much radiation you need. This is called a radiotherapy planning session. This takes about an hour and a half.
You have radiotherapy to the whole bladder. You have radiotherapy every day from Monday to Friday for 4 weeks. Each treatment takes about 15 minutes.
You have 1 treatment with mitomycin C. You have this on the first day of treatment. 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:
You have it as a slow drip via as 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.
Chemoradiotherapy and durvalumab group
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:
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 you give:
Researchers plan to look for that can help work out how well treatment is working.
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:
During chemoradiotherapy you see the doctor every week for blood tests and a check up. If you are in the durvalumab group you see the team once a month for a check up when you finish chemoradiotherapy.
You see the team 1 month after finishing treatment.
Follow up for the chemoradiotherapy group
After you finish treatment you see the doctor for a check up:
After treatment you have a CT scan or MRI scan and a cystoscope at:
The team let you know how often you have these tests after that.
Follow up for the chemoradiotherapy and durvalumab group
After you finish chemoradiotherapy you see the doctor for a check up:
After chemoradiotherapy you have a CT scan or MRI scan and a cystoscope at:
The team let you know how often you have these tests scans after that.
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 immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. If you have any of these side effects, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy. |
The most common side effects of durvalumab are:
Some people having the combination of durvalumab and chemotherapy have extra side effects. The most common include:
The most common side effects of radiotherapy include:
We have information about the side effects of:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Nicholas James
AstraZeneca
University of Birmingham
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”