Home / Clinical Trial / BCG+MM

Current Clinical Trials

BCG+MM

 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

CONSUMER TITLE

Study testing whether adding a chemotherapy drug (mitomycin) delivered directly into the bladder improves outcomes when given with standard BCG treatment after tumour removal for high-risk non–muscle-invasive bladder cancer. Participants are randomly assigned to receive either BCG+mitomycin, or BCG alone. esting whether adding a chemotherapy drug (mitomycin) delivered directly into the bladder improves outcomes when given with standard BCG treatment after tumour removal for high-risk non–muscle-invasive bladder cancer. Participants are randomly assigned to receive either BCG+mitomycin, or BCG alone.

CANCER TYPE

Bladder

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

ACKNOWLEDGEMENT

DETAILED INFORMATION

LATEST PUBLICATION