Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).
Ethan Basch, Bryce B Reeve, Sandra A Mitchell...
https://pubmed.ncbi.nlm.nih.gov/25265940Actively Recruiting
Age: 65Years +
All Genders
ID06138561
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Led by Dana-Farber Cancer Institute · Updated on 2026-02-17
180
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
N
National Comprehensive Cancer Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how best to treat older adults with advanced bladder cancer who may not tolerate all chemotherapy drugs. This study focuses on patients deemed ineligible for cisplatin treatment and evaluates the role of the Geriatric-8 survey in predicting treatment outcomes. The study also looks at how different treatments affect quality of life in this older, at-risk population. Participants receive standard non-cisplatin therapies such as carboplatin-based chemotherapy, enfortumab vedotin plus pembrolizumab, or immunotherapy. The study involves baseline and regular follow-up visits over 8 months, including questionnaires about quality of life and adverse events. Optional follow-up phone calls occur every 6 months for up to 3 years. During participation, patients complete surveys at baseline and every 3 weeks by phone or in office. Researchers monitor patient-reported side effects, quality of life, treatment changes, and acute care visits. The main outcomes measured include quality of life and adverse events over 8 months, with longer-term monitoring of survival and other health measures up to 3 years.
CONDITIONS
Brief Title
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 65 years or older (enrollment of patients age 65-70 limited to 20% of total participants)
- Diagnosed with unresectable or metastatic bladder cancer with confirmed urothelial carcinoma
- Determined to be cisplatin-ineligible by primary oncologist
- Receiving chemotherapy, immunotherapy, or combination therapy for bladder cancer
- Able and willing to provide informed consent and complete surveys in English or Spanish, alone or with assistance
You will not qualify if you...
- Choosing not to undergo cancer-directed therapy
- Receiving care outside Dana-Farber Cancer Institute or its affiliate sites
- Having advanced cognitive impairment or inability to complete surveys
- Currently receiving any other investigational agents for this condition
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or telephone)
Monitoring
Duration - Up to 8 months
Participants complete questionnaires every 3 weeks to assess quality of life, adverse events, and geriatric assessments while receiving standard non-cisplatin therapies.
Surveys every 3 weeks by telephone or in-office visit
Long-term Monitoring
Duration - Up to 3 years
Participants may have optional follow-up phone calls every 6 months to assess overall survival and long-term outcomes.
Optional phone calls every 6 months
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
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Research Team
J
Joaquim Bellmunt, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Patient-reported outcomes item selection for bladder cancer patients in chemo- or immunotherapy.
Gry Assam Taarnhøj, Henriette Lindberg, Christoffer Johansen...
https://pubmed.ncbi.nlm.nih.gov/31440865Reliability, validity, and change thresholds of the NCCN/FACT Bladder Symptom Index (NFBlSI-18) in patients with advanced urothelial cancer.
John D Peipert, Jane Chang, Si Li...
https://pubmed.ncbi.nlm.nih.gov/37823532Screening older cancer patients: first evaluation of the G-8 geriatric screening tool.
C A Bellera, M Rainfray, S Mathoulin-Pélissier...
https://pubmed.ncbi.nlm.nih.gov/22250183