Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Qol (EORTC QLQC30) absolute values and change over time
研究概览
简要总结
Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer
详细描述
Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional outcome, oncological outcome and toxicity in patients treated with definitive chemoradiation for anal cancer. Qol will be evaluated by standardized EORTC questionaires QLQ C30 and QLQ CR29. Acute and late toxicity will be assessed according to CTCAE 4.03. Oncological outcome will be assessed with regard to local and distant control, patterns of recurrence, freedom from treatment failure and overall survival. Correlations of physicians- and patients-assessed functional outcomes are planned.
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 anal cancer without distant metastases
- •indication for definitive chemoradiation therapy based on multidisciplinary evaluation
- •age >=18 years
- •written informed consent
- •ability to answer the standardized questionaires according to the treating physician
排除标准
- •age < 18 years
- •prior systemic therapy with regard to anal cancer
- •distant metastases
- •second malignancy
结局指标
主要结局
Qol (EORTC QLQC30) absolute values and change over time
时间窗: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time
Qol (EORTC QLQCR29) absolute values and change over time
时间窗: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time
次要结局
- distant control(end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266)
- overall survival(end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266)
- freedom from treatment failure(end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266)
- local control(end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266)
- acute toxicity(day 0, end of week 6, 12, 19)
- late toxicity(end of week 32, 58, 84, 110, 162, 214, 266)
研究者
Falk Roeder
Consultant
Ludwig-Maximilians - University of Munich