Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
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 neoadjuvant short term radiation or long-term chemoradiation followed by surgery
详细描述
Observational study to evaluate longitudinal quality of life in patients treated with neoadjuvant short-course Irradiation or neoadjuvant Long-Course chemoradiation followed by surgery. QoL will be evaluated by standardized EORTC questionaires QLQ C30 and 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 Patient-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 rectal Cancer without distant metastases
- •indication for neoadjuvant Radiation or chemoradiation therapy according to multidiciplinary 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 rectal Cancer
- •distant metastasis
- •second malignancy
结局指标
主要结局
QoL (EORTC QLQC30) absolute values and change over time
时间窗: short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274
Quality of life measured by EORTC questionaires QLQC30 in absolute values at different time points and change over time
QoL (EORTC QLQCR29) absolute values and change over time
时间窗: short-term radiation: day 0, end of week 1, week 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274
Quality of life measured by EORTC questionaires QLQCR29 in absolute values at different time points and change over time
次要结局
- distant control(short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274)
- local control(short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274)
- late toxicity(short-term radiation: end of week 27, 53, 105, 157, 209, 261, long-term chemoradiation: end of week 27, 40, 66, 118, 170, 222, 274)
- acute toxicity(short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14)
- freedom from Treatment failure(short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274)
- Overall survival(short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274)
研究者
Falk Roeder
Consultant
Ludwig-Maximilians - University of Munich