Status:
RECRUITING
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Comprehensive Cancer Network
EMD Serono
Conditions:
Bladder Cancer
Metastatic Bladder Cancer
Eligibility:
All Genders
65+ years
Brief 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 effe...
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 additi...
Eligibility Criteria
Inclusion
- Age ≥65-years-old (study will limit total enrollment of patients between ages 65-70 to 20% of the total study population)
- Unresectable or metastatic bladder cancer with histologically proven urothelial carcinoma. Any component of variant histology is allowed
- Cisplatin-ineligible as determined by the subject's primary oncologist
- Receiving treatment with chemotherapy (+/- immunotherapy maintenance), enfortumab vedotin-pembrolizumab combination therapy or immunotherapy alone
- Ability to understand and the willingness to sign a written informed consent document and to complete patient reported outcomes that will be in English or Spanish either alone or with assistance of study researcher or family
Exclusion
- Subjects who elect to not undergo cancer-directed therapy
- Subjects obtaining their care outside of DFCI or DFCI affiliate sites
- Advanced cognitive impairment or inability to complete surveys
- Participants who are receiving any other investigational agents for this condition (if appropriate only).
Key Trial Info
Start Date :
March 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06138561
Start Date
March 5 2024
End Date
July 1 2026
Last Update
July 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215