A trial of chemoradiotherapy and durvalumab for invasive bladder cancer (Radio)

Cancer type:

Bladder cancer

Status:

Open

Phase:

Phase 2/3

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 immune system Open a glossary item 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:

  • 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. 
You:

  • have adenocarcinoma Open a glossary item, transitional cell Open a glossary item cancer or squamous cell cancer  Open a glossary itemthat 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. 

Cancer related 
You:

  • have cancer that has spread elsewhere in the body 
  • have carcinoma in situ (CIS Open a glossary item) in much of the bladder lining as well as invasive cancer 
  • have had radiotherapy to the area between the hip bones (pelvis Open a glossary item) 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 drugs Open a glossary item and hormone therapy Open a glossary item.
  • 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 

Medical conditions
You:

  • 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 autoimmune disease Open a glossary item such as colitis or Chron’s disease. You might be able to take part if you have a skin condition called vitiligo, a skin condition that doesn’t need treatment, hair loss, problems with your thyroid gland that are stable or you have coeliac disease controlled by diet only
  • have a serious problem with your digestive system Open a glossary item that causes diarrhoea
  • have a lung condition called interstitial lung disease
  • have a problem with your bone marrow Open a glossary item and 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 pneumonitis Open a glossary item
  • have a problem with your immune system Open a glossary item and 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

Other
You

  • have had an organ transplant Open a glossary item
  • have had a live vaccination Open a glossary item
  • are pregnant or breastfeeding 
  • are allergic or sensitive to any of the trial treatments or anything they contain

Trial design

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 
  • chemoradiotherapy and durvalumab

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:

  • day 1 of week 1
  • day 1 of week 4 

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:

  • day 1 of week 2
  • day 1 of week 5 

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:

  • extra blood tests 
  • urine samples

Researchers plan to look for biomarkers Open a glossary item 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 (biopsy Open a glossary item)

The team can let you know more about these studies if you’d like to join.

Hospital visits

You see a doctor and have some tests before you join the trial. These include:

  • physical examination
  • blood tests
  • urine tests
  • heart trace (ECG Open a glossary item)
  • 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. 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:

  • every 3 months for 2 years
  • every 6 months in year 3
  • once a year in years 4 and 5

After treatment you have a CT scan or MRI scan and a cystoscope at:

  • 3 months
  • 6 month
  • 12 months

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:

  • every 3 months for 2 years
  • every 6 months in year 3
  • once a year after that 

After chemoradiotherapy you have a CT scan or MRI scan and a cystoscope at:

  • 3 months
  • 6 months
  • 12 months

The team let you know how often you have these tests scans after that.

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. 

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:

  • coughs, colds or a sore throat (an upper respiratory tract infection)
  • diarrhoea
  • 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

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:

Location

Aberdeen
Colchester
London
Newcastle upon Tyne
Peterborough
Sheffield
Sutton

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Nicholas James

Supported by

AstraZeneca
University of Birmingham

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16901

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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