NCT05438836招募中不适用
ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)
研究概览
简要总结
A single-arm, prospective, Phase II, single-center clinical trial that will investigate if daily online adaptive radiotherapy for anal cancer will significantly reduce early treatment-related GI toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).
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
- •Biopsy-verified anal cancer
- •Eligible for curative intended radiotherapy
- •Written and oral consent
排除标准
- •Other malignant disease within the past 5 years (excluding basal cell carcinoma)
结局指标
主要结局
Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)
时间窗: from mid-treatment to 3 months after end of treatment
percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity
次要结局
- Treatment Related Hospitalization(From of start of radiation therapy through 5 year follow-up)
- All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest)(from mid-treatment to 3 months after end of treatment)
- Patient Reported Outcomes (PRO)(from baseline to 5 years follow-up)
- All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities(From 3 months after end of treatment to 5 years follow-up)
- Overall Survival(From time of inclusion to death from any cause, assessed up to 5 years follow-up)
- Disease Free Survival(From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up)
- Progression Free Survival(From time of inclusion to disease progression, assessed up to 5 years follow-up)
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment(from baseline to 5 years follow-up)
研究者
Eva Serup-Hansen
Clinical oncologist, MD, PhD
Herlev Hospital
研究点 (1)
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