Understanding treatment for older patients with advanced bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Intravesical gemcitabine followed by docetaxel for high-grade BCG-unresponsive NMIBC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.