RecruitingObservational

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

NCT ID: NCT06138561Sponsor: Dana-Farber Cancer InstituteLast updated: 2026-02-17

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.

Detailed description

In this prospective, observational study, investigators are assessing the optimal approach to treating bladder cancer in older participants with other disease that might put the participants at additional risk from cancer-directed treatments. Investigators are specifically assessing the impact on adverse events, quality of life, and treatment outcomes. Additionally, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants. The research study procedures include screening for eligibility and completing questionnaires. Participation in this research study is expected to last for up to 8 months. It is expected that about 180 people will take part in this research study. The National Comprehensive Cancer Network and EMD Serono are supporting this research study by providing the necessary funds.

Arms & interventions

BehavioralGeriatric-8 Survey
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.
BehavioralNational Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)
Patient reported, sixteen question survey focused on evaluation of quality of life in patients with bladder cancer.
BehavioralPatient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
Patient-reported questionnaire that evaluates cancer-specific toxicity, developed based upon Common Terminology Criteria for Adverse Events.

Outcome measures

Primary

Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in quality of life for participants receiving Carboplatin-based chemotherapy followed by immunotherapy maintenance versus Enfortumab Vedotin-Pembrolizumab. Quality of life will be measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (NFBISI-18) version 2 questionnaire, a patient reported, eighteen question measure graded on a Likert scale.
Time frame: 8 months
Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in patient reported adverse events relevant to patients with bladder cancer between patients treated with Enfortumab Vedotin-Pembrolizumab vs. Carboplatin-based chemotherapy followed by immunotherapy maintenance. Patient reported adverse events will be assessed by the National Cancer Institute's Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire which will analyze 30 items, characterizing 16 symptomatic toxicities related treatment in terms of frequency, severity, interference (scoring from 0 to 4), and/or presence or absence (scoring 0 or 1).
Time frame: 8 months

Secondary

Frequency of acute care evaluations in patients with advanced bladder cancer deemed cisplatin-ineligible
Time frame: 8 months
Frequency of treatment changes in patients with advanced bladder cancer deemed cisplatin ineligible
Time frame: 8 months
Time to deterioration of quality of life in patients with advanced bladder cancer deemed cisplatin-ineligible
Time frame: 8 months
Overall survival in patients with advanced bladder cancer deemed cisplatin-ineligible
Time frame: Up to 3 years
Geriatric-8 scores and acute care evaluations
Time frame: 8 months
Geriatric-8 scores and treatment changes
Time frame: 8 months
Geriatric-8 scores and time to deterioration of quality of life
Time frame: 8 months
Geriatric-8 scores and overall survival
Time frame: Up to 3 years

Eligibility criteria

Sex: AllAge: 65 Years and olderHealthy volunteers: No

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).

Study locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Joaquim Bellmunt, MD, PhD · Contact

617-632-2010 Joaquim_bellmunt@dfci.harvard.edu

Joaquim Bellmunt, MD, PhD · Principal Investigator

References

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