A study of robotic assisted keyhole surgery for bladder cancer (iROC)

Cancer type:

Bladder cancer

Status:

Open

Phase:

Phase 3

This study is comparing open surgery with robotic assisted surgery for bladder cancer.

More about this trial

Surgery to remove the bladder is one of the usual treatments for bladder cancer. This is called a radical cystectomy. The standard way of doing this is through a large cut in the abdomen. This is called an open radical cystectomy.

More recently, surgeons at many UK hospitals can now remove the bladder in a different way using a type of keyhole surgery called laparoscopic or robotic cystectomy. With this type of surgery, you have several small cuts in the tummy.

Robotic radical cystectomy is a newer way of doing this surgery. The robotic machine gives the surgeon a better view of the inside of your tummy, and allows surgeons to make finer movements. The surgeon sits at a control unit a few feet away from the patient. They control the movement of a set of robotic surgical instruments, guided by a video camera.

iROC diagram

We know from published research that both types of surgery work well for bladder cancer. But researchers want to find out which type of surgery works best. They both have side effects and complications. So the researchers want to compare them to find out more.

The aims of the study are to find out:

  • which type of surgery works best
  • more about complications during and after surgery
  • about the length of time people stay in hospital
  • how surgery affects you getting up and about and back to your usual level of activity
  • more about quality of life Open a glossary item

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply.

You:

  • have bladder cancer that hasn’t grown beyond the bladder and hasn’t spread to more than 1 lymph node in the area between your hipbones (pelvis)
  • are willing to have an operation to remove the bladder
  • are well enough to be up and about for at least some of the day, even if you need help looking after yourself (performance status 0, 1, 2 or 3)
  • are at least 18 years old

Who can’t take part
You cannot join this study if any of these apply.

You:

  • have bladder cancer that has spread elsewhere in the body
  • have had surgery to your tummy (abdomen) in the past that means you aren’t suitable to have both types of surgery for bladder cancer
  • have had radiotherapy for bladder cancer
  • have cancer of the upper urinary tract (the ureters Open a glossary item or kidneys) or urethra (the tube that passes urine from the bladder to the outside of the body)
  • have any other serious medical condition or mental health problem that the study team think could affect you taking part

Trial design

This phase 3 study is taking place in the UK. The study team need about 320 people to join. It is a randomised study. You are put into 1 of 2 treatment groups by computer:

  • open radical cystectomy
  • keyhole surgery using the robotic surgery technique

Neither you nor you doctor will be able to decide which group you are in.

Research samples
The researchers will ask for a sample of your cancer that your doctor took when you had a tissue sample taken. They will also ask to take some extra blood samples and urine samples. Where possible, you have the blood tests at the same time as your routine blood tests. They plan to use the samples to find better ways of finding and treating bladder cancer in the future.

You don’t have to agree to give these samples if you don’t want to. You can still take part in the study.

Quality of life
The study team will ask you to fill out a questionnaire before you start treatment and at set times after surgery. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study. Where possible, you will complete this questionnaires at the same time as your routine appointments.

Hospital visits

You go to hospital before your surgery for a check up. This includes having a heart trace (ECG Open a glossary item) and some blood tests. These tests are standard for people having surgery for bladder cancer

The study team will ask you to do a simple exercise that involves getting up from a chair several times. This helps them assess your physical fitness.

As part of the study, the research team ask you to wear a fitness tracker similar to a Fitbit. This small device looks like a watch and it counts the number of steps you take each day. You wear it for 7 days before surgery. And for 7 days after surgery at:

  • 5 weeks
  • 12 weeks
  • 6 months
  • 1 year

The length of time you stay in hospital will vary depending on how quickly you recover after surgery. But you are likely to be in hospital for at least 10 days for both types of surgery.

You go to hospital for a check up at:

  • 5 weeks
  • 12 weeks
  • 6 months
  • 1 year

These checks up are standard for bladder cancer surgery so you shouldn’t have any additional hospital visits as a result of taking part in the study.

Side effects

Your doctor will talk to you about the possible risks and complications of surgery before you agree to have surgery to remove your bladder cancer.

There should be no extra risk to you during this study as the doctors treating you are experienced in both open and robotic surgery.

We have more information about surgery for bladder cancer.

Location

Bristol
London
Reading
Sheffield

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor James Catto
Professor John Kelly

Supported by

University College London (UCL)
The Champniss Foundation
The Urology Foundation

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15023

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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