BCG+MMC : Adding mitomycin C to Bacillus of Calmette-Guerin (BCG) as adjuvant intravesical therapy for high-risk, non-muscle invasive bladder cancer: a randomised phase 3 trial.

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy | Urinary systemBladder,

Trial Overview Read MoreRead more

This phase III trial is looking at the effect of adding mitomycin C (a chemotherapy drug) to standard treatment, in patients with invasive bladder cancer.
 

This trial is treating patients with bladder cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Adding mitomycin C to Bacillus of Calmette-Guerin (BCG) as adjuvant intravesical therapy for high-risk, non-muscle invasive bladder cancer: a randomised phase 3 trial.

Cooperative Group

Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Summary

Summary The purpose of this study is to determine the effect of adding mitomycin C (a chemotherapy drug) to best current treatment in patients with high-risk non-muscle invasive bladder cancer. Who is it for? You may be eligible to join this study if you are at least 18 years of age and have been diagnosed with non-muscle invasive bladder cancer. You should have undergone transurethral resection of the bladder tumour (TURBT) within 8 weeks prior to enrolment with no visible disease remaining. Trial details Non-muscle invasive bladder cancer is common, causes substantial suffering, and requires radical removal or irradiation of the bladder within 5 years in over 30% of people with high risk tumours despite best current treatment. Recent preliminary studies show promising results from adding mitomycin C, a chemotherapy drug, to best current treatment with BCG. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current standard treatment. This involves direct instillation of the drug, Bacillus of Calmette-Guerin (BCG) into the bladder weekly for 6 weeks, and then monthly for 10 months. Participants in the other group with receive BCG and the chemotherapy drug, mitomycin C, via instillation into the bladder weekly for 9 weeks, and then monthly for 9 months. Participants will be regularly assessed for up to 5 years in order to determine the effects of adding mitomycin C on cure rates, survival, side effects, and quality of life.

Recruiting Hospitals Read MoreRead more

Frankston Hospital
Frankston
Ms Diane Canning
dcanning@phcn.vic.gov.au
03 9784 8224

Epworth Freemasons, Medical Oncology
East Melbourne
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Not Recruiting Hospitals Read MoreRead more

Completed

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9288 3167