Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Geriatric-8 Survey
  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.
• Поведенческое National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)
  Patient reported, sixteen question survey focused on evaluation of quality of life in patients with bladder cancer.
• Поведенческое Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
  Patient-reported questionnaire that evaluates cancer-specific toxicity, developed based upon Common Terminology Criteria for Adverse Events.

Первичные конечные точки

• Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible [Срок оценки: 8 months]
• Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible [Срок оценки: 8 months]

Вторичные конечные точки (8)

• Frequency of acute care evaluations in patients with advanced bladder cancer deemed cisplatin-ineligible [Срок оценки: 8 months]
• Frequency of treatment changes in patients with advanced bladder cancer deemed cisplatin ineligible [Срок оценки: 8 months]
• Time to deterioration of quality of life in patients with advanced bladder cancer deemed cisplatin-ineligible [Срок оценки: 8 months]
• Overall survival in patients with advanced bladder cancer deemed cisplatin-ineligible [Срок оценки: Up to 3 years]
• Geriatric-8 scores and acute care evaluations [Срок оценки: 8 months]
• Geriatric-8 scores and treatment changes [Срок оценки: 8 months]
• Geriatric-8 scores and time to deterioration of quality of life [Срок оценки: 8 months]
• Geriatric-8 scores and overall survival [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Dana-Farber Cancer Institute — Boston

Публикации

• 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 criter PMID 25265940
• 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. PMID 31440865
• 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. PMID 37823532
• 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. PMID 22250183

Идентификаторы

NCT: NCT06138561 · 23-478

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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