Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer, CISTO Study

Active:	No
Cancer Type:	Bladder Cancer Unknown Primary	NCT ID:	NCT03933826
Trial Phases:		Protocol IDs:	RG1121143 (primary) NCI-2020-06082
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT03933826

Summary

This study compares therapy within the bladder (intravesical therapy) and surgery as treatment options for patients with bladder cancer. Bladder cancer is the fifth most common cancer in the United States, but not enough research is available to help patients decide between the two most common treatments: medical therapies or bladder removal. The purpose of this study is to compare how the two treatments affect patient clinical outcomes and patient and caregiver experiences. This study may help researchers improve the decision-making process about bladder cancer treatments for patients and their caregivers.

Objectives

PRIMARY OBJECTIVES:
I. To compare patient-reported and patient-centered clinical outcomes between patients undergoing radical cystectomy and those receiving bladder-sparing medical management for non-muscle-invasive bladder cancer (NMIBC) that have failed first-line Bacillus Calmette-Guerin (BCG).
II. To characterize the heterogeneity of treatments received and corresponding patient and caregiver preferences for NMIBC that have failed first-line BCG.
III. To compare the impact of radical cystectomy and medical management on caregivers of patients with NMIBC that have failed first-line BCG.

OUTLINE:
Patients complete surveys over 20 minutes at baseline and at 3, 6, 9, 12, 18, 24, 30, 36, 42, and 48 months. Caregivers complete surveys over 20 minutes at baseline and 12 months. Patients and caregivers may also participate in a phone interview over 60 minutes about experiences with bladder cancer between 6-24 months. Patients' medical records are also reviewed.

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