NCT06138561 Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
| NCT ID | NCT06138561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2024-03-05 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 investigational agents for this condition (if appropriate only).
Contact & Investigator
Joaquim Bellmunt, MD, PhD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT06138561 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06138561 currently recruiting?
Yes, NCT06138561 is actively recruiting participants. Contact the research team at Joaquim_bellmunt@dfci.harvard.edu for enrollment information.
Where is the NCT06138561 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06138561 clinical trial?
NCT06138561 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Joaquim Bellmunt, MD, PhD at Dana-Farber Cancer Institute. The trial plans to enroll 180 participants.
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