Clinical trial NCT06138561: Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Official title: Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Metastatic Bladder Cancer
Unresectable Bladder Carcinoma
Urothelial Carcinoma
Keywords: Bladder Cancer
Metastatic Bladder Cancer
Unresectable Bladder Carcinoma
Urothelial Carcinoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
name: EMD Serono
First posted: 2023-11-18
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants ≥65-years-old with metastatic or unresectable bladder cancer who are cisplatin-therapy ineligible.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
timeFrame: 8 months
measure: Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
timeFrame: 8 months
Secondary outcomes:
measure: Frequency of acute care evaluations in patients with advanced bladder cancer deemed cisplatin-ineligible
timeFrame: 8 months
measure: Frequency of treatment changes in patients with advanced bladder cancer deemed cisplatin ineligible
timeFrame: 8 months
measure: Time to deterioration of quality of life in patients with advanced bladder cancer deemed cisplatin-ineligible
timeFrame: 8 months
measure: Overall survival in patients with advanced bladder cancer deemed cisplatin-ineligible
timeFrame: Up to 3 years
measure: Geriatric-8 scores and acute care evaluations
timeFrame: 8 months
measure: Geriatric-8 scores and treatment changes
timeFrame: 8 months
measure: Geriatric-8 scores and time to deterioration of quality of life
timeFrame: 8 months
measure: Geriatric-8 scores and overall survival
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Joaquim Bellmunt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.