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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Bladder Cancer; Metastatic Bladder Cancer; Urothelial Carcinoma; Unresectable Bladder Carcinoma

Treatments: Behavioral: Geriatric-8 Survey; Behavioral: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18); Behavioral: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT06138561

23-478

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

180 participants in 1 patient group

Cisplatin-Ineligible Metastatic Bladder Cancer

Description:

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.

Treatment:

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

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

Behavioral: Geriatric-8 Survey