Bladder Cancer Clinical Trial
Official title:
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
NCT number | NCT06138561 |
Other study ID # | 23-478 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 5, 2024 |
Est. completion date | March 1, 2026 |
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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | March 1, 2026 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | EMD Serono, National Comprehensive Cancer Network |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8 months | |
Primary | 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). | 8 months | |
Secondary | 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. | 8 months | |
Secondary | 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. | 8 months | |
Secondary | 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. | 8 months | |
Secondary | 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. | Up to 3 years | |
Secondary | Geriatric-8 scores and acute care evaluations | 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. | 8 months | |
Secondary | Geriatric-8 scores and treatment changes | 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. | 8 months | |
Secondary | Geriatric-8 scores and time to deterioration of quality of life | 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. | 8 months | |
Secondary | Geriatric-8 scores and overall survival | 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 | Up to 3 years |
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