NCT06138561Recruiting
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 14 Nov 2023
- Start date
- 5 Mar 2024
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Bladder cancer
- NCT number
- NCT06138561
What you commit to
- Study type: Observational
- Planned participants: 180
- From 5 Mar 2024 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who are receiving any other investigational agents for this condition (if appropriate only).
Other illness
- Subjects who elect to not undergo cancer-directed therapy
- Advanced cognitive impairment or inability to complete surveys
Other
- Subjects obtaining their care outside of DFCI or DFCI affiliate sites
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.