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Purpose/objective(s): Recurrent T1 bladder cancer has a substantial rate of progression and is usually treated with radical cystectomy. Bladder preservation therapy is a well-established approach for the treatment of muscle invasive urothelial cancer of the bladder. RTOG 0926 was a single arm, phase II trial investigating the use of trimodality bladder preservation therapy for recurrent, high-grade non-muscle invasive urothelial cancer.Materials/methods: Eligible patients had pathologically confirmed urothelial cancer of the bladder with AJCC stage T1, Nx or N0, M0. Eligible patients had recurrence of cancer following standard therapy with transurethral resection and intravesicular biological or chemotherapy. The primary endpoint of the study was three-year rate of freedom from radical cystectomy. The sample size was 37 patients, with the hypothesis that the observed rate would be at least 75%, thereby producing a lower, one-sided 97.5% confidence limit of at least 60%. Secondary endpoints included distant disease progression at 3 and 5 years, progression to muscle invasion, disease specific and overall survival, and safety. Protocol therapy consisted of maximal transurethral resection followed by chemoradiation with 61.2 Gy in 34 daily fractions along with either cisplatin or mitomycin/5-fluorouracil for radiosensitization.Results: A total of 37 patients were enrolled between 2009-2017 in this single arm study, and 34 were evaluable. Median follow up is 4.2 years, and more than 5 years in surviving patients. The three-year freedom from cystectomy rate was 88% (lower one-sided confidence limit of 70%), meeting the primary goal of the study. Overall survival at 3 and 5 years was 69% (95% CI: 53%, 85%) and 53% (95% CI: 35%, 72%), respectively. The rate of distant metastatic disease at 3 and 5 years was 12% (95% CI: 4%, 26%) and 20% (95% CI: 8%, 37%), respectively. 8 patients died of urothelial cancer. Eleven patients had local recurrence at three years (33%; 95% CI: 17%, 49%). Twenty patients (59%) had grade 3 adverse events, most commonly anemia, gastrointestinal events, UTI, lymphopenia, metabolism and nutrition disorders, or hematuria. Two grade 4 AEs were reported, one of which (neutropenia) attributed to protocol therapy. There were no deaths due to treatment. The mean AUA score was 9.8 at baseline and 12.0 at 3 years.Conclusion: Trimodality bladder preservation therapy is an effective treatment option for patients with recurrent high grade, non-muscle invasive urothelial cancer of the bladder. At three years, nearly 90% of patients remained free of cystectomy, although the overall survival was only 69% likely reflecting the age and comorbidities of this population. Bladder preservation is an effective bladder cancer treatment strategy yet remains underutilized. [ABSTRACT FROM AUTHOR]