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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06138561
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Geriatric-8 Survey — BEHAVIORAL
    A screening tool to evaluate frailty and at-risk participants by covering multiple domains that contribute to frailty, including mobility, functional status, pharmacologic burden, and underlying psychologic burden. A total score ranges from 0 to 17 with participants scoring \> 14 points are more likely to be fit, or having a better health status, while those scoring 0 - 14 would benefit from further comprehensive geriatric assessment.
  • National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) — BEHAVIORAL
    Patient reported, sixteen question survey focused on evaluation of quality of life in patients with bladder cancer.
  • Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) — BEHAVIORAL
    Patient-reported questionnaire that evaluates cancer-specific toxicity, developed based upon Common Terminology Criteria for Adverse Events.

Study Details

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.

Key Dates

Start date
Mar 5, 2024
Status verified
Feb 2026
Primary completion
Jul 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible [ Time Frame: 8 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Joaquim Bellmunt, MD, PhD
[email protected]
617-632-2010
Joaquim Bellmunt, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Dana-Farber Cancer Institute· Boston, MA

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