A Real-life Study to Evaluate the Use of Adjuvant Treatment With Dabrafenib and Trametinib in Routine Practice in Patients With Completely Resected High-risk Stage III Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Relapse-free survival (RFS) rate
研究概览
简要总结
Non-interventional (observational) cohort prospective real life study with primary and secondary data collection from patients on adjuvant treatment with dabrafenib + trametinib in patients with completely resected high-risk stage III (stage IIIA [lymph node > 1mm], IIIB, IIIC and IIID according to AJCC 8th edition) melanoma in Turkey.
详细描述
The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting was based on collaboration with centers of excellence on melanoma patients treatment. Pre-identified centers considered as the most advanced according to their knowledge and experience, took part in the patients recruitment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (stage IIIA [lymph node > 1mm],, IIIB, IIIC, IIID) melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study;
- •V600E mutation-positive cutaneous melanoma;
- •≥ 18 years of age;
- •Written informed consent signed.
排除标准
- •Lack of basic demographic and staging data.
- •Current active participation in an interventional clinical trial for treatment of melanoma.
- •Pregnancy or breastfeeding women.
- •Current primary diagnosis of a cancer other than melanoma, that requires systemic or other treatment.
研究组 & 干预措施
dabrafenib and trametinib
patients on adjuvant treatment with dabrafenib + trametinib
干预措施: dabrafenib (Drug)
dabrafenib and trametinib
patients on adjuvant treatment with dabrafenib + trametinib
干预措施: trametinib (Drug)
结局指标
主要结局
Relapse-free survival (RFS) rate
时间窗: 12 months
RFS is the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
次要结局
- Total duration of treatment(until end of treatment or permanent treatment discontinuation)
- Number of patients on treatment(Baseline, up to 12 months)
- Rate of permanent study drug discontinuation(12 months)
- Rate of permanent drug discontinuation due to pyrexia and other AEs(12 months)
- incidence and severity of Adverse Events (AEs)(12 months)
- procedures of the management of Adverse Events (AEs)(12 months)
- Reason for treatment discontinuation(12 months)
- Average dose of dabrafenib and trametinib used during the treatment(12 months)
- Proportion of patients with dabrafenib and trametinib dose reduction during treatment(12 months)
- Reason for dabrafenib and trametinib dose reduction(12 months)
- Time since surgery(12 months)
- Type of relapse(12 months)