Digital monitoring of self-reported symptoms by patients treated with Cabozantinib plus Nivolumab for advanced clear-cell renal carcinoma: The CANIQOL multicentre study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 10
- 主要终点
- The primary endpoint is the adjustment of treatments management including any unplanned action guided by weekly digital monitoring of PRO-CTCAEs: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment
研究概览
简要总结
To evaluate the impact of digital monitoring of self-reported symptoms (PROs-CTC-AEs) to adjust treatments management of patients treated with cabozantinib plus nivolumab for advanced clear-cell RCC in real life during the first 3 months of the combined treatment
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Cabozantinib and Nivolumab
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years
- •Diagnosis of Renal Cell Carcinoma (RCC) with a clear-cell component
- •No prior systemic treatment for RCC
- •Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, according to approved local labels
- •Subjects affiliated to an appropriate social security system
- •Patient has signed informed consents obtained before any trial related activities and according to local guidelines
排除标准
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- •Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study
- •Patient with history of allergy or hypersensitivity to components of the study drugs
- •Patient with contraindication to the study drugs
- •Pregnant or lactating woman
- •Patient unable to use digital tools
- •Patient deprived of liberty or placed under the authority of a tutor
结局指标
主要结局
The primary endpoint is the adjustment of treatments management including any unplanned action guided by weekly digital monitoring of PRO-CTCAEs: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment
The primary endpoint is the adjustment of treatments management including any unplanned action guided by weekly digital monitoring of PRO-CTCAEs: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment
次要结局
未报告次要终点
研究者
Florence JOLY LOBBEDEZ
Scientific
Centre Francois Baclesse