← Back to Clinical Trials
Recruiting NCT06138561

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

◆ AI Clinical Summary
Plain-language summary for patients

Trial Parameters

Condition Bladder Cancer
Sponsor Dana-Farber Cancer Institute
Study Type OBSERVATIONAL
Phase N/A
Enrollment 180
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2024-03-05
Completion 2027-07-01
Interventions
Geriatric-8 SurveyNational 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®)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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 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

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 investig

Related Trials

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology
}