Phase III trial: Gemcitabine DNA synthesis inhibitor plus intravesical BCG for recurrent bladder cancer

This randomized Phase III trial, sponsored by Alliance for Clinical Trials in Oncology and conducted at multiple US sites, evaluates whether adding gemcitabine—a ribonucleotide reductase inhibitor that blocks DNA synthesis—to standard intravesical BCG immunotherapy improves outcomes in patients with recurrent high-grade non-muscle invasive bladder cancer. Participants are randomized to receive either BCG alone or a combined regimen with gemcitabine and BCG, with treatment schedules administered over several months.