Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at 3 cycles of chemotherapy for urothelial cancer (urinary tract cancer) (DISCUS)
This trial is comparing 3
It is for people who:
- have urothelial cancer that has grown into nearby tissues or has spread to another part of the body
- are going to have an
immunotherapycalled avelumab after chemotherapy
More about this trial
Urothelial cancer is a type of bladder cancer. Urinary tract cancer can start in the:
- tube that takes urine from the kidney to the bladder (ureter)
- tube that drains urine from the bladder and out of the body (urethra)
The lining of the urinary tract is called the urothelium, so cancer of the urinary tract can also be called urothelial cancer.
Chemotherapy is a usual treatment for urothelial cancer that has spread. It is usual to have 6 cycles of chemotherapy. You then have avelumab. It is a treatment for some people with urinary tract cancer. It is a type of immunotherapy. It helps your immune system to find and kill cancer cells.
In this trial researchers want to find out if having 3 cycles of chemotherapy makes people feel better. And if 3 cycles works just as well as 6 cycles.
In this trial you have one of the following standard combinations of chemotherapy:
The main aims of this trial are to find out if:
- 3 cycles of chemotherapy works as well as 6 cycles
- having 3 cycles improves
quality of life
- having 3 cycles reduces the side effects of treatment
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 this trial if all of the following apply. You:
- have urothelial cancer that has grown into surrounding tissues and you can’t have surgery to remove it, or the cancer has spread to another part of the body
- have cancer that your doctor can measure on a scan
- are suitable to have gemcitabine and cisplatin or gemcitabine and carboplatin
- have satisfactory blood test results
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- are up and about more than half the day, you can look after yourself but might not be able to work (performance status 0, 1 or 2)
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have cancer that has spread to the brain or spinal cord unless it isn’t causing symptoms, has been treated and is stable
- have had avelumab or a similar drug in the past
- have had treatment to the whole body (
systemic treatment)for cancer that has spread elsewhere in the body or grown into the surrounding tissues. You may be able to take part if you had treatment with a platinum drugsuch as carboplatin or cisplatin.
- have an area of cancer that is bleeding
- have had another cancer that has got worse or needed treatment in the past 3 years unless it has a low chance of coming back. You can join if it was successfully treated
non melanoma skin cancer, carcinoma in situ ( CIS), localised prostate cancer or ductal carcinoma in situ ( DCIS) of the breast
- are taking part in another clinical trial unless it doesn’t involve a treatment
You cannot join this trial if any of these apply. You:
- are having
steroidsunless you are on a low dose
- have had treatment to stimulate the
immune systemThis includes interferon in the last 4 weeks or if treatment hasn’t completely cleared your body.
- have had a heart attack or stroke in the last 6 months or a significant
heart problemthat needs treatment. The trial team check if you have a heart condition before you join the trial.
- have had a transplant with someone else’s cells (
allogeneic transplant) or an organ transplant
- have had recent radiotherapy
- have had major surgery in the last 4 weeks
- have scarring on the lungs or active inflammation of the lungs (
- have HIV, an active hepatitis B or hepatitis C infection, active tuberculosis or any other severe infection that needs treatment
- have an
autoimmune conditionthat needs treatment apart from certain ones. Your doctor will know about this.
- have side effects from treatment that aren’t getting better unless they are mild. You can join the trial if you have hearing loss or tingling in your hands or feet.
You can’t join this trial if any of these apply. You:
- are allergic to any of the drugs on the trial or anything they contain
- can’t have the chemotherapy drugs used in this trial for any reason
- are pregnant or breastfeeding
- have had a
live vaccinationwithin the last 4 weeks. Please note that the current approved COVID-19 vaccines are allowed as they aren’t live.
This phase 2 trial is taking place in the UK, Spain and France. The team need about 244 people to take part including about 90 from the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.
You have 1 of the following:
- 3 cycles of chemotherapy followed by avelumab
- 6 cycles of chemotherapy followed by avelumab
Your doctor will decide whether you have gemcitabine and cisplatin or gemcitabine and carboplatin. They will discuss this with you.
Depending on which group you are in you have 3 cycles or 6 cycles. Each treatment cycle lasts for 21 days. In each cycle you have:
- gemcitabine on day 1 and day 8
- cisplatin or carboplatin on day 1
You have gemcitabine, cisplatin and carboplatin as a drip into a vein. It takes about 60 minutes each time.
When you finish chemotherapy you start having avelumab. You have this as a drip into a vein. Each treatment cycle is 28 days. You have avelumab every 2 weeks. It takes about 60 minutes each time.
You have avelumab for up to 2 years as long as treatment is working and the side effects aren’t too bad.
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- 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 team ask you to take part in a
The trial team will tell you more about the sub study. You can say no if you don’t want to take part. It won’t affect you taking part in the rest of the trial.
Samples for research
You give some extra blood and urine samples during treatment. You give the samples at specific times and the trial team will give you more information about this.
The trial team will ask to use a tissue sample of your cancer you gave when you had surgery or a biopsy.
They plan to use the samples to:
- see how well the treatment is working
- look at
genesin cancer cells to understand more about urinary tract cancer
- look for substances called
biomarkersto help work out why treatment might work for some people and not for others
You see a doctor and have some tests before taking part. These tests include:
You have all your treatment in the hospital on the day ward. You shouldn’t need to stay overnight.
You have a CT or MRI scan at:
- 2 months and then
- every 10 weeks
You stop trial treatment and scans if your cancer gets worse. Your doctor will talk to you about other treatment options.
You see the trial team for a check up 30 days after your lost dose of treatment. They then call you every 3 months for 2 years to see how you are getting on. Or they may check your medical notes.
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.
Avelumab 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 avelumab are:
- an increased risk of tiredness and breathlessness (
thyroidnot making enough hormones causing tiredness, weight gain, feeling cold and constipation
- feeling or being sick
- tummy pain
- tiredness (fatigue)
- chills and high temperatures (fever)
- swelling of the arms and legs
- weight loss and loss of appetite
- high blood pressure
- skin rash
- cough, shortness of breath or lung inflammation
- headache, back and joint pain
- a reaction during the infusion causing a skin rash, itching, swelling of the lips, face or throat, breathing difficulties, fever and chills. Your nurse will give you medicines beforehand to try to prevent a reaction.
We have information about:
How to join a clinical trial
Professor Thomas Powles
Queen Mary University of London