Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06138561

Conditions

Bladder Cancer

Metastatic Bladder Cancer

Unresectable Bladder Carcinoma

Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Geriatric-8 Survey

National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)

Study Details

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.

Conditions

Bladder Cancer

Metastatic Bladder Cancer

Unresectable Bladder Carcinoma

Urothelial Carcinoma

Study ID

NCT06138561

Start date

Mar 5, 2024

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Geriatric-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.

National 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.

Patient-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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Joaquim Bellmunt, MD, PhD

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

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Joaquim Bellmunt, MD, PhD

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

Principal Investigator:

Joaquim Bellmunt, MD, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Bladder Cancer
  • Metastatic Bladder Cancer
  • Unresectable Bladder Carcinoma
  • Urothelial Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-02-17.