Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorDana-Farber Cancer Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial population
Participants ≥65-years-old with metastatic or unresectable bladder cancer who are cisplatin-therapy ineligible.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Geriatric-8 Survey
BehavioralA 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.
National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)
BehavioralPatient reported, sixteen question survey focused on evaluation of quality of life in patients with bladder cancer.
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
BehavioralPatient-reported questionnaire that evaluates cancer-specific toxicity, developed based upon Common Terminology Criteria for Adverse Events.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Cisplatin-Ineligible Metastatic Bladder Cancer3 interventions
Trial outcomes
Primary outcomes
1
Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in quality of life for participants receiving Carboplatin-based chemotherapy followed by immunotherapy maintenance versus Enfortumab Vedotin-Pembrolizumab. Quality of life will be measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (NFBISI-18) version 2 questionnaire, a patient reported, eighteen question measure graded on a Likert scale.
Time frame
8 months2
Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in patient reported adverse events relevant to patients with bladder cancer between patients treated with Enfortumab Vedotin-Pembrolizumab vs. Carboplatin-based chemotherapy followed by immunotherapy maintenance. Patient reported adverse events will be assessed by the National Cancer Institute's Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire which will analyze 30 items, characterizing 16 symptomatic toxicities related treatment in terms of frequency, severity, interference (scoring from 0 to 4), and/or presence or absence (scoring 0 or 1).
Time frame
8 monthsSecondary outcomes
1
Frequency of acute care evaluations in patients with advanced bladder cancer deemed cisplatin-ineligible
In frail and at-risk patients as well as all study participants, will evaluate the difference in need for acute care evaluations in patients treated with Enfortumab Vedotin-Pembrolizumab versus Carboplatin-based chemotherapy followed by immunotherapy maintenance. Need for acute care evaluations will be are defined as the need for either hospitalizations or emergency department visits.
Time frame
8 months2
Frequency of treatment changes in patients with advanced bladder cancer deemed cisplatin ineligible
In frail and at-risk patients as well as all study participants, will evaluate the difference in need for treatment changes in patients treated with Enfortumab Vedotin-Pembrolizumab versus Carboplatin-based chemotherapy followed by immunotherapy maintenance. Treatment changes will be defined as dose adjustments, treatment disruption, or early treatment discontinuation.
Time frame
8 months3
Time to deterioration of quality of life in patients with advanced bladder cancer deemed cisplatin-ineligible
In frail and at-risk patients as well as all study participants, will evaluate the difference in time to deterioration of quality of life in patients treated with Enfortumab Vedotin-Pembrolizumab versus Carboplatin-based chemotherapy followed by immunotherapy maintenance. The time to deterioration of quality of life will be defined as a ≥ 3 point decrease from initial NFBISI-18 score on two consecutive evaluations (spaced 3 weeks apart) and will be analyzed using Kaplan-Meier estimates.
Time frame
8 months4
Overall survival in patients with advanced bladder cancer deemed cisplatin-ineligible
In frail and at-risk patients as well as all study participants, will evaluate the difference in overall survival in patients treated with Enfortumab Vedotin-Pembrolizumab versus Carboplatin-based chemotherapy followed by immunotherapy maintenance. Overall survival will be defined as time from treatment initiation to death due to any cause or censored at date of last known alive. It will be analyzed using Kaplan-Meier estimates.
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
National Comprehensive Cancer Network
Collaborator
EMD Serono
Collaborator
Source ClinicalTrials.gov