Clinical trial · Observational
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
NCT06138561CI-TRIAL-00103364recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Bladder Carcinoma | Bladder Carcinoma | CURATED_BROADER | 0.78 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Geriatric-8 Survey | Behavioral | — | UNRESOLVED |
| National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) | Behavioral | — | UNRESOLVED |
| Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cisplatin-Ineligible Metastatic Bladder Cancer
- description
- 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.
- interventionNames
- Behavioral: Geriatric-8 Survey
- Behavioral: 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®)
Primary outcomes (2)
- measure
- Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
- timeFrame
- 8 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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).
References
Publications (4)
- BACKGROUNDBasch 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. PMID 25265940
- BACKGROUNDTaarnhoj 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. PMID 31440865
- BACKGROUNDPeipert 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. PMID 37823532
- BACKGROUNDBellera 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. PMID 22250183