Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
NCT06138561 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180
Last updated 2026-02-17
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.
Conditions
- Bladder Cancer
- Metastatic Bladder Cancer
- Unresectable Bladder Carcinoma
- Urothelial Carcinoma
Interventions
- BEHAVIORAL
-
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.
- 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.
- 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.
Sponsors & Collaborators
-
National Comprehensive Cancer Network
collaborator NETWORK - collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Joaquim Bellmunt, MD, PhD · Dana-Farber Cancer Institute
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-05
- Primary Completion
- 2027-07-01
- Completion
- 2028-01-01
Countries
- United States
Study Locations
More Related Trials
-
Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer
NCT06412874 ·Status: COMPLETED
-
Prospective Multicentric Evaluation of a Bladder Preservation Strategy
NCT01093066 ·Status: TERMINATED ·Phase: PHASE2
-
Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer
NCT05203913 ·Status: RECRUITING ·Phase: PHASE2
-
Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
NCT02178241 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer
NCT00055601 ·Status: COMPLETED ·Phase: PHASE2
-
Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer
NCT02716961 ·Status: UNKNOWN ·Phase: NA
-
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
NCT01104350 ·Status: COMPLETED ·Phase: PHASE1
-
Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy
NCT02145390 ·Status: TERMINATED ·Phase: NA
-
Survival Benefits of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer
NCT06727214 ·Status: NOT_YET_RECRUITING
-
Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery
NCT00777491 ·Status: COMPLETED ·Phase: PHASE2
-
First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma
NCT03324282 ·Status: TERMINATED ·Phase: PHASE2
-
Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer
NCT06325423 ·Status: NOT_YET_RECRUITING
-
A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder
NCT05137262 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer
NCT05822934 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer
NCT05531123 ·Status: RECRUITING ·Phase: PHASE2
-
Drug Screening Using IMD in Bladder Cancer
NCT06204614 ·Status: ENROLLING_BY_INVITATION ·Phase: EARLY_PHASE1
-
Chemotherapy Combined With Tislelizumab as Bladder Sparing Option for Patients With Muscle Invasive Bladder Cancer
NCT04909775 ·Status: UNKNOWN ·Phase: PHASE2
-
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
NCT03732677 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
NCT00045630 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer
NCT01801644 ·Status: COMPLETED ·Phase: NA
-
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
NCT03661320 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
NCT06388720 ·Status: RECRUITING ·Phase: PHASE2
-
Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer
NCT03617913 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study
NCT05626101 ·Status: RECRUITING ·Phase: NA
-
Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.
NCT00191711 ·Status: COMPLETED ·Phase: PHASE2