Collaborative Wilms Tumour Africa Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Event free survival
研究概览
简要总结
Significant progress has been made in the treatment of Wilms tumor in high income countries, where survival is now around 85% - 90%. Survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment.
A comprehensive treatment guideline was introduced in Malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. Survival has increased to around 50%; 95% of children completed their treatment. A multi-disciplinary group of African clinicians and 'state of the art' experts produced a consensus treatment guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year.
The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete treatment and <10% treatment related mortality. Other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.
详细描述
Patients are treated according to standard care. Data are documented on presentation at diagnosis, response of the tumor, findings at surgery and pathology, treatment given and outcome of the patients.
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
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 18 years
- •Diagnosis Wilms tumour
排除标准
- 未提供
结局指标
主要结局
Event free survival
时间窗: 2 years
Percentage of patients with no event after two years of follow up.
次要结局
未报告次要终点
研究者
Trijn Israels
Paediatric Oncologist, MD PhD
Amsterdam UMC, location VUmc
