Understanding treatment for older patients with advanced bladder cancer
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Dana-Farber Cancer Institute · NCT06138561
This study is testing a new way to help older patients with advanced bladder cancer who can't take certain chemotherapy drugs by using a survey to see how well treatments work and how they affect their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute (other) |
| Drugs / interventions | enfortumab, pembrolizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06138561 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve treatment strategies for older patients with metastatic bladder cancer who are ineligible for cisplatin-based chemotherapy. Investigators will assess the effectiveness of the Geriatric-8 survey in predicting treatment outcomes and quality of life for these patients. The study will involve screening for eligibility and collecting patient-reported outcomes over a period of up to 8 months, with approximately 180 participants expected to enroll. The research is supported by the National Comprehensive Cancer Network and EMD Serono.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older with unresectable or metastatic bladder cancer who are deemed cisplatin-ineligible.
Not a fit: Patients who choose not to undergo cancer-directed therapy or have advanced cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and effective treatment options for older patients with advanced bladder cancer.
How similar studies have performed: While this approach is focused on geriatric assessments in bladder cancer, similar studies have shown promise in improving treatment outcomes for older cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Joaquim Bellmunt, MD, PhD — Dana-Farber Cancer Institute
- Study coordinator: Joaquim Bellmunt, MD, PhD
- Email: Joaquim_bellmunt@dfci.harvard.edu
- Phone: 617-632-2010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Cancer, Metastatic Bladder Cancer, Unresectable Bladder Carcinoma, Urothelial Carcinoma