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

NCT ID: NCT06138561

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2026-07-01

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.

Conditions

Bladder Cancer; Metastatic Bladder Cancer; Unresectable Bladder Carcinoma; Urothelial Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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:

• 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.

Geriatric-8 Survey

Intervention Type: BEHAVIORAL

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.

National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)

Intervention Type: BEHAVIORAL

Patient reported, sixteen question survey focused on evaluation of quality of life in patients with bladder cancer.

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)

Intervention Type: BEHAVIORAL

Patient-reported questionnaire that evaluates cancer-specific toxicity, developed based upon Common Terminology Criteria for Adverse Events.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

G8

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

EMD Serono

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Joaquim Bellmunt, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquim Bellmunt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joaquim Bellmunt, MD, PhD

Role: CONTACT

Joaquim_bellmunt@dfci.harvard.edu

617-632-2010

Facility Contacts

Joaquim Bellmunt, MD, PhD

Role: primary

Joaquim_bellmunt@dfci.harvard.edu

617-632-2010

References

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.

Reference Type: BACKGROUND

PMID: 25265940 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31440865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37823532 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22250183 (View on PubMed)

Other Identifiers

23-478

Identifier Type: -

Identifier Source: org_study_id