PROSPECTIVE RANDOMISED CLINICAL TRIAL TO EVALUATE THE EARLY RECURRENCE RATE IN NON-MUSCLE INVASIVE BLADDER CANCER BETWEEN THE USE OF CHEMOHYPERTHERMIA (QH) WITH MITOMYCIN-C PRIOR TO TRANSURETHRAL BLADDER RESECTION IN A MAJOR OUTPATIENT SURGERY PROGRAMME AND TREATMENT WITH MITOMYCIN-C IN NORMOTHERMIA POST-RESECTION.
This study is for people with early-stage bladder cancer that hasn't grown into the bladder muscle. Researchers want to find out the best way to prevent the cancer from returning. They are comparing two different methods of giving a cancer-fighting medicine called Mitomycin-C directly into the bladder. One method uses heat alongside the medicine before a bladder surgery. The other method gives the medicine without heat after the surgery. Both approaches aim to reduce the chance of the cancer coming back. The study will help doctors understand which method is more effective for patients in a day-case surgery setting.
At a glance
What is this study about?
This study is about a type of bladder cancer that's caught early, before it has spread deep into the bladder muscle. This is often called 'non-muscle invasive bladder cancer'. While surgery is usually done to remove these growths, there's a risk the cancer might come back. To try and stop this, doctors often give medicine directly into the bladder.
This research is comparing two ways of giving a medicine called Mitomycin-C. One group of patients will have their bladder warmed up while the medicine is put in, and this happens *before* they have keyhole surgery (called Transurethral Bladder Resection, or TURBT) to remove the bladder growths. The other group will have the same medicine put into their bladder *after* their surgery, but without the heat. The main goal is to see which of these methods is better at preventing the cancer from returning early on.
Understanding which treatment is more effective could help many people with this type of bladder cancer. If one method works better, it could become a standard treatment, offering patients a better chance of staying cancer-free for longer. This study is taking place in an outpatient setting, meaning patients can often go home the same day after their procedure.
Key takeaways
- Studies early-stage bladder cancer that hasn't spread.
- Compares two ways of giving anti-cancer medicine into the bladder.
- One method uses heat with medicine before surgery, the other medicine without heat after surgery.
- Aims to find out which method is better at preventing cancer recurrence.
- Participants will be aged 18 or over, with non-muscle invasive bladder cancer.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women. The most important thing is that you have been diagnosed with an early form of bladder cancer that has not spread into the bladder muscle – this is often called 'non-muscle invasive bladder cancer'.
There might be other health conditions or medicines you are taking that would mean this study isn't right for you. The study team will check all your medical information carefully to make sure it's safe and appropriate for you to take part.
Your doctor will discuss all the details with you to see if you meet all the requirements for this particular study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with bladder cancer?
- Has your doctor told you your bladder cancer has NOT spread into the muscle wall?
- Are you able to attend appointments at a hospital or clinic?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two treatment groups, like flipping a coin. You won't get to choose which group you're in. Depending on your group, you'll either receive the heated medicine before your bladder surgery, or the medicine without heat after your surgery. Both procedures involve the medicine being put directly into your bladder through a small tube. You will have regular check-ups and tests, likely involving follow-up appointments and scans or procedures to check the inside of your bladder (cystoscopies), to see if the cancer has returned. The total duration of your participation, including follow-up, will be explained by the study team.
Potential risks and benefits
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Common questions
What is 'non-muscle invasive bladder cancer'?
This is an early stage of bladder cancer where the cancer cells are only in the inner lining of the bladder and haven't grown into the deeper muscle wall.
What is Mitomycin-C?
It's a type of medicine that helps kill cancer cells. In this study, it's put directly into the bladder.
What does 'chemohyperthermia' mean?
It means chemotherapy (cancer medicine) with heat. In this study, it's about warming the bladder while the medicine is inside it, as heat might help the medicine work better.
What is a 'Transurethral Bladder Resection' (TURBT)?
It's a common operation to remove bladder growths using special instruments passed through the tube you urinate from (urethra), so there are no cuts on your skin.
Why is this study important?
It aims to find a better way to stop early bladder cancer from coming back, which could improve outcomes for many patients.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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