Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.
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 verified anal squamous cell carcinoma
- •Radiotherapy or chemoradiotherapy planned
- •ECOG performance status 0-2
- •>= 18 years of age
- •Signed informed consent and expected cooperation of the patients for treatment and follow up
排除标准
- •Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
结局指标
主要结局
Disease-free survival
时间窗: 3 years
次要结局
- Improvement of faecal incontinence(5 years)
- Pain relief of palliative radiotherapy(5 years)
- Prediction of local recurrence(2 years)
- Biomarker ability to predict local recurrence rate(5 years)
研究者
Marianne Grønlie Guren
MD PhD
Oslo University Hospital