- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06138561
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Joaquim Bellmunt, MD, PhD
- Phone Number: 617-632-2010
- Email: Joaquim_bellmunt@dfci.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
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Principal Investigator:
- Joaquim Bellmunt, MD, PhD
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Contact:
- Joaquim Bellmunt, MD, PhD
- Phone Number: 617-632-2010
- Email: Joaquim_bellmunt@dfci.harvard.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Cisplatin-Ineligible Metastatic Bladder Cancer
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:
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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.
Other Names:
Patient reported, sixteen question survey focused on evaluation of quality of life in patients with bladder cancer.
Patient-reported questionnaire that evaluates cancer-specific toxicity, developed based upon Common Terminology Criteria for Adverse Events.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
Time Frame: 8 months
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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.
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8 months
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Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
Time Frame: 8 months
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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).
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8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to deterioration of quality of life in patients with advanced bladder cancer deemed cisplatin-ineligible
Time Frame: 8 months
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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.
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8 months
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Overall survival in patients with advanced bladder cancer deemed cisplatin-ineligible
Time Frame: Up to 3 years
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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.
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Up to 3 years
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Geriatric-8 scores and acute care evaluations
Time Frame: 8 months
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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.
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8 months
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Geriatric-8 scores and treatment changes
Time Frame: 8 months
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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.
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8 months
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Geriatric-8 scores and time to deterioration of quality of life
Time Frame: 8 months
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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.
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8 months
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Geriatric-8 scores and overall survival
Time Frame: Up to 3 years
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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
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Up to 3 years
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Frequency of acute care evaluations in patients with advanced bladder cancer deemed cisplatin-ineligible
Time Frame: 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.
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8 months
|
Frequency of treatment changes in patients with advanced bladder cancer deemed cisplatin ineligible
Time Frame: 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.
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8 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joaquim Bellmunt, MD, PhD, Dana-Farber Cancer Institute
Publications and helpful links
General Publications
- Bellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.
- Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014 Sep 29;106(9):dju244. doi: 10.1093/jnci/dju244. Print 2014 Sep.
- Taarnhoj GA, Lindberg H, Johansen C, Pappot H. Patient-reported outcomes item selection for bladder cancer patients in chemo- or immunotherapy. J Patient Rep Outcomes. 2019 Aug 22;3(1):56. doi: 10.1186/s41687-019-0141-2.
- Peipert JD, Chang J, Li S, di Pietro A, Cislo P, Cappelleri JC, Cella D. Reliability, validity, and change thresholds of the NCCN/FACT Bladder Symptom Index (NFBlSI-18) in patients with advanced urothelial cancer. Cancer. 2024 Jan 1;130(1):31-40. doi: 10.1002/cncr.35025. Epub 2023 Oct 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
Other Study ID Numbers
- 23-478
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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