Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer, CISTO Study
Bladder Cancer
Unknown Primary
18 Years and older, Male and Female
RG1121143 (primary)
NCI-2020-06082
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.
Eligibility
- Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
* Pathology documentation from any hospital/clinic/medical center, and
* More than 50% urothelial carcinoma component in the specimen
- History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1
- Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time
- Received at least one instillation of any intravesical agent within previous 12 months
- Caregiver
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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