BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301)

Table 1 Schedule of assessments

	Baseline	Induction	Maintenance	Year 2 to Year 5
Blood tests ^a	X		Week 13
Urine culture	X		Week 13
Cystoscopy ^b	TURBT	After last instillation	After 4^th, 7^th and last instillation	3 monthly (Year 2); 6 monthly (Years 3 and 4); at 5 years
Health-related quality of life	X	Weeks 3,6,9,13	Weeks 25,37,49	3 monthly (Year 2); 6 monthly (Years 3 and 4); at 5 years
Assessments ^c	X	Prior to each treatment	Prior to each treatment	3 monthly (Year 2); 6 monthly (Years 3 and 4); at 5 years

^aFull blood count, urea and electrolytes, liver function tests
^bUnder local anaesthesia (LA) except at end of induction and maintenance when must be under general anaesthesia (GA) with biopsies
^cAssessments include those for treatment toxicity, symptoms of UTI, adverse events, resource use and patient status

ISSN: 1471-2407