Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Side effects
研究概览
简要总结
The study aims to provide a setup for collecting radiotherapy-related toxicity data, loco-regional control, and overall survival data for all Danish cancer patients undergoing reirradiation with high dose intention or with the aim of local tumour control; with the ultimate aim of providing safe reirradiation to a larger group of patients. To build a reirradiation cohort database for future research
详细描述
Reirradiation of recurrent or new tumours has been associated with high rates of severe and even lethal toxicity in some previous reports [Andratscske2023]. This has led to many patients not being offered high dose reirradiation, even though they may potentially benefit from effective local treatment. Thus, it is extremely important to establish solid evidence of the risk of severe toxicity, to enable radiotherapy to be offered to these patients on an equal footing with patients treated for their first cancer.
This prospective registration study will form the basis of a database enabling us to learn more about which patients are suitable for reirradiation, optimal constraints for organs at risk in reirradiation, overall survival, etc.
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
- •High dose reirradiation (reirradiation type I or II or repeat organ irradiation delivered with the aim of local control)
- •Read Danish (for questionnaires + patient information)
- •Life expectancy due to age and co-morbidity of ≥6 months.
- •The general condition must be sufficient to tolerate persistent significant side effects
- •Histological or imaging verified loco-regional recurrence, solitary oligo metastasis or new primary
- •Age ≥18 years
- •Signed informed consent, updated annually
- •Expected follow up physical, by video, by phone or likely contact at a relevant oncological department
- •Available dose plan(s) from primary (and prior) radiotherapy course(s) (with 3D reconstruction of previous plans, available port film, or drawings). Multiple re-treatments are allowed (new inclusion and baseline registration)
排除标准
- •The primary and reirradiation treatments may not be quasi-simultaneous (i.e. the two treatments should be planned independently)
- •Inability to attend full course of radiotherapy
- •Purpose of radiotherapy is ONLY palliation of symptoms
研究组 & 干预措施
Reirradiation
All patients treated with reirradiation with the aim of local control
干预措施: Reirradiation (Radiation)
结局指标
主要结局
Side effects
时间窗: 5 years
CTCAE side effects
次要结局
未报告次要终点