Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reirradiation.
- Who it may be relevant to
- Registry conditions: Radiotherapy Side Effect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Detailed description
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.
Interventions
- Radiation Reirradiation
reirradiation with all available modalities can be included
Primary outcome measures
- Side effects [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07528339 · PRIOR