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

Launched by DANA-FARBER CANCER INSTITUTE · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on finding the best ways to treat older patients with advanced bladder cancer who cannot tolerate certain chemotherapy drugs, specifically cisplatin. Researchers want to learn how effective a simple questionnaire, called the Geriatric-8, can be in predicting how well older patients will respond to different cancer treatments. They are also looking at how these treatments affect the quality of life for older patients and those at higher risk.

To participate in this trial, you must be at least 65 years old and have bladder cancer that cannot be surgically removed or has spread to other areas of the body. You should also be ineligible for cisplatin treatment, as determined by your doctor. If you join, you'll receive chemotherapy, immunotherapy, or a combination of both, and you’ll need to complete some surveys in English or Spanish. It’s important that you can understand the information and consent to participate, possibly with help from a family member or study staff. This study is currently recruiting participants, and your involvement could help improve treatment options for others with similar conditions.

Gender

ALL

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).