"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of cetuximab with chemotherapy and radiotherapy for muscle invasive bladder cancer (TUXEDO)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called cetuximab alongside radiotherapy and chemotherapy for bladder cancer that has grown into the muscle layer (invasive bladder cancer). This trial is supported by Cancer Research UK.
More about this trial
If bladder cancer has grown into the muscle layer of the bladder wall, doctors can treat it with radiotherapy. We know from research that having chemotherapy at the same time as radiotherapy reduces the risk of the cancer coming back. Having chemotherapy before radiotherapy can also help.
Researchers now want to see if having a drug called cetuximab at the same time as radiotherapy and chemotherapy can further improve treatment. Cetuximab is a type of biological therapy called a monoclonal antibody.
The trial is in 2 parts. In part 1, the researchers look at chemotherapy alongside cetuximab and radiotherapy. In part 2, they look at just this treatment in a larger number of people to see if it reduces the risk of bladder cancer coming back.
The people taking part may have already had some chemotherapy to shrink their cancer before having radiotherapy. The aim of the study is to find out more about the best way to treat people with muscle invasive bladder cancer.
Who can enter
You may be able to enter this trial if you
- Have bladder cancer that has grown into the muscle layer of the bladder wall, but has not spread to your
lymph nodesor to other parts of your body
- Are able to have radiotherapy
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for up to a year afterwards if there is any chance you or your partner could become pregnant
If you had chemotherapy after your diagnosis (surgery) but before joining the TUXEDO trial, then your cancer must have responded well to this treatment.
You cannot enter this trial if you
- Have carcinoma in situ of the bladder that is in more than 1 place in the bladder lining or is in a different part of the bladder from the invasive cancer
- Have transitional cell cancer (TCC) in your kidney or the tube connecting the kidney to the bladder or TCC of your prostate
- Have had any other type of cancer that the researchers think could affect the trial
- Have taken part in another clinical trial in the last month
- Have kidney damage from previous chemotherapy
- Have had radiotherapy that included the area between your hip bones (your
- Have a build up of urine in your kidney (
hydronephrosis) unless this has been treated
- Have had both your hips replaced
- Have inflammatory bowel disease
- Have had a heart attack in the last 12 months or have certain other heart problems
- Have any other condition that the trial doctors think could affect you taking part
- Are pregnant or breastfeeding
The trial is in 2 parts. In the 1st part, a few people join the trial to see how well treatment works. You have cetuximab and the chemotherapy drugs mitomycin C and 5FU at the same time as radiotherapy
If this works well, the researchers will test this treatment in a larger number of people. This is part 2 (or phase 2) of the trial. The treatment takes about 8 weeks all together. You have treatment as follows:
- Radiotherapy every day from Monday to Friday for just over 6 weeks
- Cetuximab through a drip into a vein a week before starting radiotherapy and then once a week for the next 7 weeks. This takes 2 hours the first time and then 1 hour in the following weeks
- Mitomycin C and 5FU in the 1st week of radiotherapy and 5FU alone in the 4th week. You have mitomycin C as an injection into a vein. You have the 5FU through a drip into a vein over 5 days each time
You will have a central line put in before you start treatment. This means you can have the 5FU via a small portable pump that you carry around and you don’t have to stay in hospital.
The trial team will ask you to fill out some questionnaires when you join the trial, at the end of your treatment and at each of your follow up visits. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study. You don’t have to take part in the quality of life study if you don’t want to. You can still take part in the trial.
The trial team may also ask you to agree to them using any tissue samples (biopsies) you had taken during either a cystoscopy or surgery. They will also ask if you will give some extra blood samples and also some urine samples. These will be used for research into improving bladder cancer treatments. If you agree to give these additional samples the trial team will explain what is involved. You do not have to give these samples if you don’t want to. You can still take part in the trial.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- CT scan or MRI scan
- Blood tests
- Urine tests
- A test to look at the inside of your bladder (a rigid cystoscopy)
You go to hospital every day for just over 6 weeks to have radiotherapy. On some days you also have cetuximab or chemotherapy (or both).
You have regular blood tests during treatment. When you finish treatment you see the trial team and have more blood tests about a month later.
About 3 months after you finish treatment, you see the trial team again and have a physical examination, blood tests, a test to look at the inside of your bladder (a cystoscopy) and a CT or MRI scan. You then have follow up visits 6, 10 and 16 months after finishing treatment. You have a physical examination, a scan and a cystoscopy each time.
The common side effects of cetuximab include
- Skin reactions including a rash or itchy skin
- Low magnesium levels in your blood which can make you feel weak or confused
- Shortness of breath
- Changes to your liver
- Inflammation of the lining of your intestine, mouth and nose which can cause nosebleeds
- Tiredness (fatigue)
- Sore mouth
- Feeling or being sick
- Gritty eyes and blurred vision
- Redness of the skin on your hands or feet
- A drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Cough or shortness of breath
- Hair loss is possible but rare with these 2 drugs.
We have more information about the side effects of bladder radiotherapy.
How to join a clinical trial
Professor Nick James
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Merck Serono UK
NIHR Clinical Research Network: Cancer
University of Birmingham
This is Cancer Research UK trial number CRUK/09/021.