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Trial Title:
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
NCT ID:
NCT06138561
Condition:
Bladder Cancer
Metastatic Bladder Cancer
Unresectable Bladder Carcinoma
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Conditions: Keywords:
Bladder Cancer
Metastatic Bladder Cancer
Unresectable Bladder Carcinoma
Urothelial Carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Geriatric-8 Survey
Description:
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.
Arm group label:
Cisplatin-Ineligible Metastatic Bladder Cancer
Other name:
G8
Intervention type:
Behavioral
Intervention name:
National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)
Description:
Patient reported, sixteen question survey focused on evaluation of quality of life in
patients with bladder cancer.
Arm group label:
Cisplatin-Ineligible Metastatic Bladder Cancer
Intervention type:
Behavioral
Intervention name:
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
Description:
Patient-reported questionnaire that evaluates cancer-specific toxicity, developed based
upon Common Terminology Criteria for Adverse Events.
Arm group label:
Cisplatin-Ineligible Metastatic 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.
Detailed description:
In this prospective, observational study, investigators are assessing the optimal
approach to treating bladder cancer in older participants with other disease that might
put the participants at additional risk from cancer-directed treatments. Investigators
are specifically assessing the impact on adverse events, quality of life, and treatment
outcomes. Additionally, investigators are assessing the role of the survey, the
Geriatric-8, and its ability to predict outcomes in older participants.
The research study procedures include screening for eligibility and completing
questionnaires.
Participation in this research study is expected to last for up to 8 months.
It is expected that about 180 people will take part in this research study.
The National Comprehensive Cancer Network and EMD Serono are supporting this research
study by providing the necessary funds.
Criteria for eligibility:
Study pop:
Participants ≥65-years-old with metastatic or unresectable bladder cancer who are
cisplatin-therapy ineligible.
Sampling method:
Non-Probability Sample
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).
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joaquim Bellmunt, MD, PhD
Phone:
617-632-2010
Email:
Joaquim_bellmunt@dfci.harvard.edu
Investigator:
Last name:
Joaquim Bellmunt, MD, PhD
Email:
Principal Investigator
Start date:
March 5, 2024
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Comprehensive Cancer Network
Agency class:
Other
Collaborator:
Agency:
EMD Serono
Agency class:
Industry
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06138561
