All studies
Active not recruitingPHASE2INTERVENTIONAL

Study of Tumour Focused Radiotherapy for Bladder Cancer

This study, called RAIDER, is for people with bladder cancer that has spread into the muscle wall. This type of cancer is serious and usually treated with surgery or daily radiotherapy. RAIDER explores new ways to give radiotherapy to hopefully improve how well it works. Normally, radiotherapy treats the whole bladder with the same dose. RAIDER tries different approaches: either 'adaptive radiotherapy' which adjusts the treatment plan, or 'tumour-focused radiotherapy' which aims a higher dose directly at the cancer. The study will compare these newer methods with standard radiotherapy to see if they can target the tumour more effectively and if any side effects are acceptable. If successful, this could lead to even better treatments for bladder cancer in the future.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Institute of Cancer Research, United Kingdom
Enrolment target
345
Start
21 Oct 2015
Estimated completion
01 Mar 2029

What is this study about?

Bladder cancer is a common cancer in the UK, and for about a quarter of people, it has grown into the muscle wall of the bladder. When this happens, it's called 'muscle-invasive bladder cancer' and it's a serious condition. The usual treatments are either an operation to remove the bladder or daily radiotherapy, which uses strong X-rays to kill cancer cells, given for several weeks.

The RAIDER study wants to find better ways to give radiotherapy. Right now, radiotherapy usually treats the whole bladder with the same dose. But new ways of treating cancer are being developed. One of these is called 'adaptive radiotherapy', where the treatment plan can be changed based on how your bladder looks on the day of treatment. Another is 'tumour-focused radiotherapy', where the highest dose of radiation is aimed specifically at the cancer within the bladder, rather than the whole bladder.

This study will involve at least 240 people with muscle-invasive bladder cancer. Participants will be divided into three groups: one will receive the standard whole bladder radiotherapy, another will get tumour-focused adaptive radiotherapy with a normal dose, and the third group will get tumour-focused adaptive radiotherapy with a slightly higher dose to the tumour. The main goal is to see if these newer, more targeted methods can successfully deliver more radiation to the tumour compared to standard treatment, and importantly, if any long-term side effects are manageable. If the study shows good results, it could lead to further studies to prove whether these newer treatments are more effective at beating bladder cancer than current methods.

Key takeaways

  • RAIDER is looking for better ways to treat muscle-invasive bladder cancer with radiotherapy.
  • It compares standard radiotherapy with new methods that target the tumour more precisely.
  • The study aims to see if targeted radiotherapy is effective and has acceptable side effects.
  • Participants will have regular check-ups for several years after treatment.
  • The results could lead to improved bladder cancer treatments in the future.

Who may be eligible?

To join this study, you need to be at least 16 years old. You must have bladder cancer that has been confirmed by tests as a specific type (transitional cell carcinoma) and has grown into the muscle layer of your bladder, but has not spread to other parts of your body like lymph nodes or other organs. The doctors must be able to clearly see your tumour on scans or a bladder map.

It's important that you are generally well enough to have a full course of radiotherapy treatment. You should also be willing and able to follow all the study instructions and attend all follow-up appointments. The cancer should be in one main spot within your bladder.

You would not be able to join if your cancer has spread to your lymph nodes or other parts of your body. Other reasons you couldn't join include if you have more than one invasive tumour in your bladder, if you have cancer in your upper urinary tract or urethra at the same time, if you are pregnant, or if you have had other cancers recently (with some exceptions like certain skin cancers or very low-risk prostate cancer). Also, if you have bilateral hip replacements or other conditions that your doctor thinks would make radiotherapy unsafe for you, like previous radiotherapy to the pelvis or inflammatory bowel disease, you wouldn't be able to participate.

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.

  1. Do you have bladder cancer that has grown into the muscle?
  2. Is your cancer only in your bladder and not spread elsewhere?
  3. Are you at least 16 years old?
  4. Are you well enough for a course of radiotherapy?
  5. Can you attend regular hospital visits for treatment and follow-up?
  6. Do you have a single tumor that can be clearly seen on scans?
Answer every question to see your result.

What does participation involve?

If you take part in the RAIDER study, you will be assigned to one of three treatment groups: standard radiotherapy, targeted adaptive radiotherapy with a normal dose, or targeted adaptive radiotherapy with a slightly higher dose to the tumour. The radiotherapy itself will be given over several weeks, as is usual for this type of treatment. Some participants might also receive chemotherapy alongside their radiotherapy, if their clinical team decides this is appropriate for their care.

After your radiotherapy finishes, you will have several follow-up appointments to check on your health and see if the cancer has returned. These appointments will be at 4 weeks, then at 3, 6, 9, 12, 18, and 24 months after your radiotherapy. After the first two years, you will continue to have yearly check-ups. During these visits, doctors will monitor your progress, look for any signs of the cancer returning, and help manage any symptoms you might be experiencing. The study plans to establish the best way to deliver treatment and what the long term side effects are, likely lasting several years for individual participants.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, potentially more effective, and more targeted radiotherapy treatment for your bladder cancer compared to standard care. However, as with any medical treatment, there are potential risks and side effects from radiotherapy, which will be carefully monitored. The study specifically aims to check if the long-term side effects of the new targeted treatments are acceptable. You will be given full information about all possible risks and side effects before you decide to join. Remember, taking part in any clinical trial is entirely voluntary, and you are free to withdraw at any time without it affecting your future medical care.

Locations (49)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Riverina Cancer Care Centre
    Verified postcode
    Wagga Wagga, Australia
  • Princess Alexandra Hospital
    Verified postcode
    Brisbane, Australia
  • Townsville General Hospital
    Verified postcode
    Douglas, Australia
  • Radiation Oncology Mater Centre QLD
    Verified postcode
    South Brisbane, Australia
  • Royal Hobart Hospital
    Verified postcode
    Hobart, Australia
  • Austin Hospital
    Verified postcode
    Melbourne, Australia
  • Sir Charles Gairdner Hospital
    Verified postcode
    Nedlands, Australia
  • Auckland Hospital
    Verified postcode
    Auckland, New Zealand
  • Christchurch Hospital
    Verified postcode
    Christchurch, New Zealand
  • Waikato
    Verified postcode
    Hamilton, New Zealand
  • Torbay District General Hospital
    Verified postcode
    Torquay, United Kingdom
  • Barts Health NHS Trust
    Verified postcode
    London, United Kingdom

Common questions

What is 'muscle-invasive bladder cancer'?

This is when bladder cancer has grown into the muscular wall of the bladder, making it a more serious type of cancer that needs focused treatment.

What is adaptive radiotherapy?

Adaptive radiotherapy is a newer way of giving radiation where the treatment plan can be adjusted, or 'adapted', based on small changes in your body each day, to make the treatment more precise.

Will I definitely get the new treatment if I join?

No, you will be randomly assigned to one of three groups: standard radiotherapy, or one of the two new targeted radiotherapy methods. You will not be able to choose which group you are in.

How long will I have to be involved in the study?

You'll have regular hospital visits for check-ups for two years after your radiotherapy, and then once a year after that to monitor your health and any side effects.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting the care you receive from your doctors.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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