ClinicalTrialsFinder
RecruitingNCT06138561

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

Sponsor

Dana-Farber Cancer Institute

Enrollment

180 participants

Start Date

Mar 5, 2024

Study Type

OBSERVATIONAL

Conditions

Urothelial CarcinomaBladder CancerUnresectable Bladder CarcinomaMetastatic Bladder Cancer

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This observational study looks at how older adults with metastatic bladder cancer who cannot receive the standard drug cisplatin are managed in real-world clinical settings. It also studies how comprehensive assessments of older patients' health (called geriatric assessments) affect treatment decisions and outcomes. **You may be eligible if...** - You are 65 or older - You have unresectable or metastatic bladder cancer confirmed by biopsy (urothelial carcinoma) - Your doctor has determined you are not a good candidate for cisplatin chemotherapy - You are receiving treatment with chemotherapy with or without immunotherapy, enfortumab vedotin plus pembrolizumab, or immunotherapy alone - You are able to understand and sign a consent form **You may NOT be eligible if...** - You are under 65 years old - You are eligible for cisplatin - You are not receiving one of the specified treatment regimens Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALGeriatric-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.

BEHAVIORALNational 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.

BEHAVIORALPatient-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.

Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06138561

Related Trials

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT000268841 location

DESTINY-PANTUMOUR04

NCT0712400017 locations

Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

NCT072417936 locations

A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)

NCT0741929521 locations

Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence

NCT066827281 location