Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
Prospective observational study to evaluate the Quality of life based on standardized EORTC questionaires as well as toxicities, functional and oncological outcomes in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer.
详细描述
Prospective observational study to evaluate the Quality of life based in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer. QoL will be evaluated by standardized EORTC questionaires. Acute and late toxicity will be assessed according to CTCAE 4.03. Outcome measures will include local Control, distant Control, freedom from Treatment failure and overall survival. Correlations are planned between Patient- and physician-assessed functional Outcome.
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
- •histologically proven esophageal Cancer (SCC or adenocarcinoma) without distant metastases (except supraclavicular nodes)
- •indication for neoadjuvant or definitive chemoradiation using either cisplatin/5-FU or carboplatin/paclitaxel with curative intent
- •age >= 18 years
- •written informed consent
- •ability to answer the standardized questionaires according to the treating physician
排除标准
- •age < 18 years
- •Treatment with palliative intent
- •distant metastases (except supraclavicular nodes)
- •second malignancy
- •Prior systemic treatment for esophageal Cancer
- •Treatment in an interventional study
结局指标
主要结局
Quality of life
时间窗: planning CT (day 0), week 4 of RT, 6 weeks after end of RT, 3 months after end of RT, 6 months after end of RT, 12 months after end of RT, 24, 36, 48, and 60 months after end of RT
Quality of life measured by standardized EORTC questionaires
次要结局
- Distant Control(3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT)
- acute toxicity(end of RT, 6 weeks after end of RT, 3 months after end of RT)
- Local control(3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT)
- late toxicity(6 months after end of RT, 9 months after end of RT, 12, 24, 36, 48, 60 months after end of RT)
- freedom from treatment failure(3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT)
- Overall survival(3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT)
研究者
Falk Roeder
Consultant
Ludwig-Maximilians - University of Munich