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

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 , transitional cell cancer or squamous cell cancer  that 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 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 drugs  and 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 

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 active autoimmune disease  or 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 system  that causes diarrhoea
• have a lung condition called interstitial lung disease
• have a problem with your bone marrow 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
• have a problem with your immune system  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
• 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