By now, we became familiar with Gemcitabine and Docetaxel (GEM/DOC) sequential treatment for BCG unresponsive and alternative to BCG when BCG is in shortage. Several participants on this forum posted their experience wit GEM/DOC including its efficacy and side effects. Also retrospective studies often conducted by University of Iowa team who developed the GEM/DOC treatment protocol and tested its efficacy for BCG naive and BCG experienced patients with very good outcomes. But, those studies did not include randomized comparisons between GEM/DOC and BCG. Phase 3 BRIDGE trial plans to recruit about1000 patients and test sites are located several states, with Colorado hosting the most test sites (19). Participants will be followed for 5 years after the completion of the treatment. Patients who are selected for BCG will received usual 6 weeks induction + 3 weeks maintenance at months 3,6,12,18,24, 30. Patients with GEM/DOC will receive treatment of 6 weeks + monthly for up to 2 year. The completion of the trial is expected to be in 2029.
medicine.uiowa.edu/content/alternative-bladder-cancer-treatment-emerges-amid-worldwide-shortage-standard-care-bcg
www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2022-04864&r=1