BCG+MM Trial

Trial Title:

Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: a randomised phase III trial

Trial Acronym:

BCG+MM

Protocol Number:

ANZUP 1301

Trial Design:

Open label, multi-centre, two-stage, phase III trial

ANZ Study Chairs:

Professor Dickon Hayne

ANZ Coordinating Centre:

NHMRC Clinical Trials Centre

Trial Coordinator:

Mariya Walker

Trial Email:

bcgmmc@ctc.usyd.edu.au

Patient Population:

Adults with resected, high-risk NMIBC (high grade Ta or any grade T1) suitable for intravesical chemotherapy treatment.

Intervention:

Participants will be randomised to receive either:

Arm A – standard treatment. Intravesical BCG alone. Consisting of 6 x weekly induction followed by 10 x monthly maintenance

Arm B – experimental. Intravesical BCG + MM. Consisting of 9 x weekly induction followed by 9 x monthly maintenance.

Primary Outcome:

To compare disease free survival (evidence of transitional cell carcinoma [TCC] or death, DFS) between the two treatment arms

Secondary Outcomes:

To compare between the two treatment arms:
2) Activity (clear cystoscopy at 3 months)
3) Time to recurrence (recurrence of TCC, TTR)
4) Time to progression (recurrence of higher grade or stage, TTP)
5) Safety (adverse events graded according to CTC AE V4.03)
6) Health-related quality of life (HRQL) (QLQ-BLS24, QLQ-C30 & I-PSS)
7) Overall survival time (death from any cause)
8) Feasibility (compliance with intravesical therapy)
9) Marginal resource use (e.g. number of GP visits, number of outpatient and emergency department visits, number of inpatient admissions and the number of days admitted)

Status:

Active and Recruiting

Sites Recruiting:

NSW
• Concord Repatriation General Hospital
• Northern Cancer Institute
• Southside Cancer Care Centre 
• Sydney Adventist Hospital Clinical Trials Unit
• The Tweed Hospital
• Westmead Hospital

VIC
• Austin Hospital
• Epworth HealthCare (Richmond)
• Footscray Hospital
• Frankston Hospital
• Royal Melbourne Hospital
• The Alfred Hospital

WA
• Fiona Stanley Hospital
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