Bladder — In Follow-up

Non-muscle invasive bladder cancer is common and causes substantial suffering. It requires removal or irradiation of the bladder within five years in more than 30% of people with high-risk tumours, despite best current treatment.

Recent preliminary studies show promising results from adding mitomycin (MM), a chemotherapy drug, to current treatment with BCG (Bacillus Calmette-Guérin, a strain of modified bacteria which stimulates an immune response to early cancer cells). This randomised trial will determine the effects of adding mitomycin on cure rates, survival, side effects and quality of life. This could potentially provide a simple and cost-effective treatment for patients who suffer from this cancer.

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC). This ANZUP investigator-initiated study is being funded by Cancer Australia and the National Health and Medical Research Council. We acknowledge Omegapharm and Merck Sharp & Dohme for providing the study drugs.

The BCG+MM trial is now closed to recruitment, and enrolled 501 patients from across Australia and one site in the UK.
If you think this trial might be right for you, please ask your doctor.
Trial Title
Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: a randomised phase III trial
Cancer Type
Trial Status
In Follow-up
Protocol Number
ANZUP 1301
Co-ordinating centre
Study Chair
Professor Dickon Hayne
Patient Population
Adults with resected, high-risk NMIBC (high grade Ta or any grade T1) suitable for intravesical chemotherapy treatment.
Recruitment Target
Stage 1: 130 patients Stage 2: 370 patients
Detailed Information
Further Information
Latest Publication
Participating Centres
Concord Repatriation General Hospital
Westmead Hospital - Western Sydney Local Health District
John Hunter Hospital
Northern Cancer Institute
Southside Cancer Care Centre
The Tweed Hospital
Nepean Hospital
Sydney Adventist Hospital

Epworth HealthCare (Richmond)
Royal Melbourne Hospital
Alfred Health - The Alfred Hospital
Austin Health
Frankston Hospital
Western Health - Footscray Hospital

Redcliffe Hospital

Fiona Stanley Hospital

Nottingham University Hospitals NHS Trust - City Hospital Campus