RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-05
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06138561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥65-years-old (study will limit total enrollment of patients between ages 65-70 to 20% of the total study population)
  2. * Unresectable or metastatic bladder cancer with histologically proven urothelial carcinoma. Any component of variant histology is allowed
  3. * Cisplatin-ineligible as determined by the subject's primary oncologist
  4. * Receiving treatment with chemotherapy (+/- immunotherapy maintenance), enfortumab vedotin-pembrolizumab combination therapy or immunotherapy alone
  5. * 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
  1. * Subjects who elect to not undergo cancer-directed therapy
  2. * Subjects obtaining their care outside of DFCI or DFCI affiliate sites
  3. * Advanced cognitive impairment or inability to complete surveys
  4. * Participants who are receiving any other investigational agents for this condition (if appropriate only).

Contacts and Locations

Study Contact

Joaquim Bellmunt, MD, PhD
CONTACT
617-632-2010
Joaquim_bellmunt@dfci.harvard.edu

Principal Investigator

Joaquim Bellmunt, MD, PhD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Joaquim Bellmunt, MD, PhD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-05
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2024-03-05
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • Bladder Cancer
  • Metastatic Bladder Cancer
  • Unresectable Bladder Carcinoma
  • Urothelial Carcinoma

Additional Relevant MeSH Terms

  • Bladder Cancer
  • Metastatic Bladder Cancer
  • Unresectable Bladder Carcinoma
  • Urothelial Carcinoma