A trial looking at heated mitomycin C chemotherapy for bladder cancer (HIVEC II)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Results

Phase:

Phase 2

This trial looked at having heated mitomycin C into the bladder for non muscle invasive bladder cancer. Non muscle invasive bladder cancer means the cancer is only in the lining of the bladder. It has not grown into the deeper layers of the bladder wall.

This trial was for people with newly diagnosed bladder cancer or bladder cancer that had come back after initial treatment.

The trial was open for people to join between 2014 and 2017. The team published the results in 2023.

More about this trial

Surgery, followed by mitomycin C chemotherapy is a treatment option for non muscle invasive bladder cancer. This was the standard treatment Open a glossary item when the researchers did this trial. You have the chemotherapy directly into the bladder. This is called intravesical treatment. 

Doctors were looking at ways to improve treatment for non muscle invasive bladder cancer. They thought that heating the chemotherapy could help. They used a device to increase the temperature of the chemotherapy. The temperature was between 42° and 44° degrees centigrade. The heated chemotherapy was then washed through the bladder. 

This was a phase 2 trial. Everyone had 6 chemotherapy treatments:

  • half had heated mitomycin C 
  • half had mitomycin C at room temperature 

The main aims of this trial were to find out:

  • which way of having mitomycin C works better to control cancer growth 
  • more about the side effects

Summary of results

A total of 259 people joined this trial. They were put into a treatment group at random

  • 131 were in the heated mitomycin C group
  • 128 were in the room temperature mitomycin C group (the usual way of having it)

At 2 years, the trial team looked at whose cancer had come back (recurred). They found this happened in:

  • 42 out of 131 people (32%) in the heated mitomycin C group 
  • 49 out of 128 people (38%) in the group who had mitomycin C in the usual way 

The results for these two groups do look different. But it is more likely that the difference is due to chance, and not differences in how well the treatments worked. 

At 2 years, the team also looked at:

  • the number of people living with no signs of cancer
  • how long before the cancer started to grow again
  • how long people lived for

They found there was no difference between the two groups.

They also looked at who completed treatment. Those who had heated chemotherapy were less likely to complete all their chemotherapy treatments. 

Side effects
Most people had at least 1 side effect from treatment. Most of the side effects were mild or didn’t last long. 

A few people had more severe side effects. This was:

  • 13 out of 131 people in the heated mitomycin C group
  • 7 out of 128 people in the group who had mitomycin C in the usual way 

The more severe side effects of having heated mitomycin C were:

  • pain in the area between the hips (pelvis Open a glossary item) or pain when weeing
  • blood in wee

The more severe side effect of having mitomycin C in the usual way was a skin rash. 

Conclusion
The trial team found that having heated mitomycin C into the bladder didn’t improve treatment for non muscle invasive bladder cancer. It didn’t work better than having mitomycin C into the bladder at room temperature. 

Sometimes trials show a way of giving treatment isn’t useful for a particular type or stage of cancer. But these trials still add to our knowledge and understanding of cancer and how to treat it.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Adjuvant Intravesical Chemohyperthermia Versus Passive Chemotherapy in Patients with Intermediate-risk Non–muscle invasive Bladder Cancer (HIVEC-II): A Phase 2, Open-label, Randomised Controlled Trial 
W S Tan and others
European Urology 2023, Volume 83, issue 6, pages 497-504

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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 John Kelly

Supported by

Combat Medical Ltd
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Queen Mary University of London
National Institute for Health Research University College London
University College London Hospital Biomedical Research Centre

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11639

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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