![]() When documented, pathologic size at cystoscopy and TURBT will take precedence over radiographic measurements of tumor size. A single muscle-invasive bladder tumor measuring ≤5 cm in size as defined by the surgeons at cystoscopic evaluation. No concomitant multifocal carcinoma in situ a single focus is allowed Medically appropriate candidate for radical cystectomy as assessed by surgeon 20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specimen available (for sequencing), with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides. The diagnostic TURBT sample must have been obtained within 60 days prior to registration Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or examination under anesthesia (EUA). Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Step 1 Patient Registration Eligibility Criteria Infiltrating Bladder Urothelial Carcinoma.Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach To determine the 3-year event free survival, defined as the proportion of patients without invasive or metastatic recurrence following definitive gemcitabine hydrochloride (gemcitabine) and cisplatin (standard or dose-dense) chemotherapy in those patients whose pre-treatment transurethral resection of bladder tumor (TURBT) tumors harbor deleterious DDR gene alterations and who achieve = cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.Īfter completion of study treatment, participants are followed up for 5 years. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Grants and Research Funding Opportunities.
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