Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. 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.

Trial Details

NCT ID

NCT03609216

Phase

PHASE2

Sponsor

Alliance for Clinical Trials in Oncology

Status

RECRUITING

Cancer Type

Urothelial Carcinoma Bladder Cancer

Interventions

Gemcitabine Hydrochloride
Cisplatin
Pegfilgrastim
Conventional Surgery
Radical Cystectomy
Chemoradiotherapy

Locations (sample)

Fairbanks, Alaska, United States|64.83778,-147.71639
Goodyear, Arizona, United States|33.43532,-112.35821
Fort Smith, Arkansas, United States|35.38592,-94.39855
Arroyo Grande, California, United States|35.11859,-120.59073
Rocklin, California, United States|38.79073,-121.23578

Key Eligibility Criteria

Step 1 Patient Registration Eligibility Criteria
Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histo…
20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specime…
Clinical stage T2-T4aN0/xM0 disease

For full eligibility, visit ClinicalTrials.gov.

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