jRCTs011210055已完成不适用
A multicenter study to explore the benefit of patient-reported outcome (PRO:ePRO/paper-PRO) monitoring in the treatment of patients with advanced renal cell carcinoma with cabozantinib.
未提供0 个研究点目标入组 105 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- Deterioration rate of the Functional Assessment of Cancer Therapy (FACT) -Kidney Cancer Symptom Index (FKSI -19)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Patients aged 18 years or older at the time of informed consent (regardless of gender)
- •2.Patients with clinically or histologically confirmed renal cell carcinoma who are deemed eligible for cabozantinib according to the package insert.
- •3.Patients who are receiving treatment including immune checkpoint inhibitors (Pembrolizumab,
- •ipilimumab, nivolumab, avelumab, etc.) for renal cell carcinoma.
- •4.Patients who are scheduled to start treatment with cabozantinib monotherapy for unresectable or metastatic renal cell carcinoma (treatment start dose:60mg/day)
- •5.Karnofsky Performance Status (KPS) score >= 60%
- •6.Patients capable of handling electronic devices (may require some assistance)
- •7.CT or MRI including the chest and abdomen has been assessed or is expected to be assessed within 28 days prior to initiation of cabozantinib treatment (Imaging is recommended as much as possible for both CT and MRI.)
- •8.Patients expected to survive for at least 6 months at the time of informed consent
- •9.In the opinion of the investigator or sub-investigator, the subject is capable of understanding and complying with protocol requirements.
- •10.Patients who can sign and date a written informed consent form prior to enrollment in the study
排除标准
- •1.Patients with treatment-emergent adverse events that have not resolved to baseline or Grade <= 1 according to CTCAE version 5.
- •unless clinically insignificant or stable on supportive care.
- •2.Pregnant or breastfeeding women, or women who are unable to prevent pregnancy during the study and for 4 months after the last dose.
- •3.Patients unable to swallow tablets
- •4.Patients previously treated with cabozantinib
- •5.History of allergy or hypersensitivity to any of the ingredients of cabozantinib.
- •6.Current or planned participation in another clinical study or a clinical study involving an intervention.
- •7.Other patients considered ineligible for the study by the investigator or sub-investigator
结局指标
主要结局
Deterioration rate of the Functional Assessment of Cancer Therapy (FACT) -Kidney Cancer Symptom Index (FKSI -19)
时间窗: during the period until Week 24 or discontinuation
A decrease of >= 5 points from baseline is defined as deterioration, and the percentage of study subjects whose FKSI-19 assessment after the start of cabozantinib was reduced by at least one time from baseline by at least 5 points.
Deterioration rate of FKSI
A decrease of >= 5 points from baseline is defined as deterioration, and the percentage of study subjects whose FKSI-19 assessment after the start of cabozantinib was reduced by at least one time from baseline by at least 5 points.
次要结局
- Progression free survival (PFS)(Week 24)
- Dose adjustment(during the study)
- Questionnaire survey of investigators and study subjects
- ePRO/paper-PRO adherence rates
研究者
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