NCT06138561

Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to better understand how to best treat participants with advanced bladder cancer who may not be able to tolerate all of the chemotherapy drugs that have been shown to be effective. In this study, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants undergoing cancer treatments. Additionally, investigators are evaluating the differential impact of treatments on quality of life in an older and at risk population.

Detailed description

In this prospective, observational study, investigators are assessing the optimal approach to treating bladder cancer in older participants with other disease that might put the participants at additional risk from cancer-directed treatments. Investigators are specifically assessing the impact on adverse events, quality of life, and treatment outcomes. Additionally, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants. The research study procedures include screening for eligibility and completing questionnaires. Participation in this research study is expected to last for up to 8 months. It is expected that about 180 people will take part in this research study. The National Comprehensive Cancer Network and EMD Serono are supporting this research study by providing the necessary funds.

Conditions

• Bladder Cancer
• Metastatic Bladder Cancer
• Unresectable Bladder Carcinoma
• Urothelial Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Geriatric-8 Survey	A screening tool to evaluate frailty and at-risk participants by covering multiple domains that contribute to frailty, including mobility, functional status, pharmacologic burden, and underlying psychologic burden. A total score ranges from 0 to 17 with participants scoring \> 14 points are more likely to be fit, or having a better health status, while those scoring 0 - 14 would benefit from further comprehensive geriatric assessment.
BEHAVIORAL	National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)	Patient reported, sixteen question survey focused on evaluation of quality of life in patients with bladder cancer.
BEHAVIORAL	Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)	Patient-reported questionnaire that evaluates cancer-specific toxicity, developed based upon Common Terminology Criteria for Adverse Events.

Timeline

• Start date: 2024-03-05
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2023-11-18
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States