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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Joaquim Bellmunt, MD, PhD
Joaquim_bellmunt@dfci.harvard.edu
617-632-2010
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 180
Treatments
Cisplatin-Ineligible Metastatic Bladder Cancer
Participants receiving standard of care non-cisplatin based therapy (carboplatin-based chemotherapy, enfortumab vedotin plus pembrolizumab or immunotherapy) and will complete study procedures as outlined below:~* Baseline visit with questionnaires.~* Complete surveys every 3 weeks by telephone or by in-office visit for 8 months.~* Optional follow-up phone calls every 6 months for up to 3 years.
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: National Comprehensive Cancer Network, EMD Serono

This content was sourced from clinicaltrials.gov

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