Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Geriatric-8 Survey (Behavioral)
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.
干预措施: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) (Behavioral)
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.
干预措施: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) (Behavioral)
结局指标
主要结局
Patient reported adverse events in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
时间窗: 8 months
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in patient reported adverse events relevant to patients with bladder cancer between patients treated with Enfortumab Vedotin-Pembrolizumab vs. Carboplatin-based chemotherapy followed by immunotherapy maintenance. Patient reported adverse events will be assessed by the National Cancer Institute's Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire which will analyze 30 items, characterizing 16 symptomatic toxicities related treatment in terms of frequency, severity, interference (scoring from 0 to 4), and/or presence or absence (scoring 0 or 1).
Quality of life in frail and at-risk patients with advanced bladder cancer deemed cisplatin-ineligible
时间窗: 8 months
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in quality of life for participants receiving Carboplatin-based chemotherapy followed by immunotherapy maintenance versus Enfortumab Vedotin-Pembrolizumab. Quality of life will be measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (NFBISI-18) version 2 questionnaire, a patient reported, eighteen question measure graded on a Likert scale.
次要结局
- Frequency of treatment changes in patients with advanced bladder cancer deemed cisplatin ineligible(8 months)
- Geriatric-8 scores and acute care evaluations(8 months)
- Geriatric-8 scores and treatment changes(8 months)
- Frequency of acute care evaluations in patients with advanced bladder cancer deemed cisplatin-ineligible(8 months)
- Geriatric-8 scores and overall survival(Up to 3 years)
- Time to deterioration of quality of life in patients with advanced bladder cancer deemed cisplatin-ineligible(8 months)
- Overall survival in patients with advanced bladder cancer deemed cisplatin-ineligible(Up to 3 years)
- Geriatric-8 scores and time to deterioration of quality of life(8 months)
研究者
Joaquim Bellmunt, MD
Principal Investigator
Dana-Farber Cancer Institute