Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorDana-Farber Cancer Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Geriatric-8 Survey
- National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)
- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
Treatment groups
180 Participants
are divided into 1 treatment groupSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
National Comprehensive Cancer Network
Collaborator
EMD Serono
Collaborator
Source ClinicalTrials.gov