This protocol addresses patients with a primary low-grade or grade 1 urothelial carcinoma of the bladder at stage Ta or T1, with no concurrent carcinoma in situ (CIS). It is a first-line protocol — the tumour has not been treated before.
The qualifying patient presents with a primary (not a recurrence), single TaT1 LG/G1 bladder tumour less than 3 cm in diameter and no CIS — or a primary Ta LG/G1 tumour without CIS with at most one additional clinical risk factor. There is no muscle invasion and no concurrent carcinoma in situ.
Management begins with transurethral resection of the bladder tumour (TURBT), followed immediately by a single postoperative intravesical instillation of chemotherapy administered within 24 hours. The full protocol specifies the eligible agents, procedural requirements, and decision criteria.