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

RECRUITINGSponsored by Dana-Farber Cancer Institute
Actively Recruiting
SponsorDana-Farber Cancer Institute
Started2024-03-05
Est. completion2027-07-01
Eligibility
Age65 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 65 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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).

Conditions5

Bladder CancerCancerMetastatic Bladder CancerUnresectable Bladder CarcinomaUrothelial Carcinoma

Locations1 site

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Joaquim Bellmunt, MD, PhD617-632-2010Joaquim_bellmunt@dfci.harvard.edu

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