Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
- Conditions
- Unresectable Bladder CarcinomaBladder CancerMetastatic Bladder CancerUrothelial Carcinoma
- Interventions
- Behavioral: Geriatric-8 SurveyBehavioral: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)Behavioral: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
- Registration Number
- NCT06138561
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cisplatin-Ineligible Metastatic Bladder Cancer Geriatric-8 Survey Participants receiving standard of care non-cisplatin based therapy (carboplatin-based chemotherapy, enfortumab vedotin plus pembrolizumab or immunotherapy) and will complete study procedures as outlined below: * Baseline visit with questionnaires. * Complete surveys every 3 weeks by telephone or by in-office visit for 8 months. * Optional follow-up phone calls every 6 months for up to 3 years. Cisplatin-Ineligible Metastatic Bladder Cancer National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) Participants receiving standard of care non-cisplatin based therapy (carboplatin-based chemotherapy, enfortumab vedotin plus pembrolizumab or immunotherapy) and will complete study procedures as outlined below: * Baseline visit with questionnaires. * Complete surveys every 3 weeks by telephone or by in-office visit for 8 months. * Optional follow-up phone calls every 6 months for up to 3 years. Cisplatin-Ineligible Metastatic Bladder Cancer Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Participants receiving standard of care non-cisplatin based therapy (carboplatin-based chemotherapy, enfortumab vedotin plus pembrolizumab or immunotherapy) and will complete study procedures as outlined below: * Baseline visit with questionnaires. * Complete surveys every 3 weeks by telephone or by in-office visit for 8 months. * Optional follow-up phone calls every 6 months for up to 3 years.
- Primary Outcome Measures
Name Time Method Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible 8 months 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).
Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible 8 months 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.
- Secondary Outcome Measures
Name Time Method Frequency of treatment changes in patients with advanced bladder cancer deemed cisplatin ineligible 8 months 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.
Geriatric-8 scores and acute care evaluations 8 months In all study participants, will evaluate the association of geriatric-8 scores with need for acute care evaluations. Acute care evaluations are defined as the need for either hospitalizations or emergency department visits, which will be descriptively summarized.
Geriatric-8 scores and treatment changes 8 months In all study participants, will evaluate the association of geriatric-8 scores with need for treatment changes.Treatment changes will be defined dose adjustments, treatment disruption, or early treatment discontinuation.
Frequency of acute care evaluations in patients with advanced bladder cancer deemed cisplatin-ineligible 8 months 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.
Geriatric-8 scores and overall survival Up to 3 years In all study participants, will evaluate the association of geriatric-8 scores with overall survival. 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 according to G8 score
Time to deterioration of quality of life in patients with advanced bladder cancer deemed cisplatin-ineligible 8 months 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.
Overall survival in patients with advanced bladder cancer deemed cisplatin-ineligible Up to 3 years 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.
Geriatric-8 scores and time to deterioration of quality of life 8 months In all study participants, will evaluate the association of geriatric-8 scores with time to deterioration of quality of life. 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 according to G8 score.
Trial Locations
- Locations (1)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States