Radiotherapy Side EffectPRIORNCT07528339
Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK)
An observational study of Radiotherapy Side Effect, run by University of Aarhus.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy Side Effect
- What is being tested?
- Reirradiation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2037
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: No guidelines are provided on the selection of patients for high dose reirradiation. All patients are eligible for the database if treated with reirradiation with the aim of local control.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Camilla JS Kronborg, PhD, MD contact
About this study
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
Read the 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.
- Conditions
- Radiotherapy Side Effect
- Being tested
- Reirradiation
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReirradiationRadiation
reirradiation with all available modalities can be included
| Study group | Role | What they receive |
|---|---|---|
| Reirradiation | All patients treated with reirradiation with the aim of local control Receives: Radiation: Reirradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects
CTCAE side effects
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2032 (estimated)
- Study completion31 Mar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528339
- Sponsor's protocol ID
- PRIOR
- Acronym
- PRIOR
- Status last verified
- Feb 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A predefined central data analysis plan has not been established for this study. Instead, data analyses will primarily be undertaken within the framework of individual sub-projects, each of which must be reviewed and approved by the steering committee.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK)
- ClinicalTrials.gov ID
- NCT07528339
- Acronym / sponsor ID
- PRIOR / PRIOR
- Conditions
- Radiotherapy Side Effect
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2032 (estimated)
- Study completion
- 31 Mar 2037 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reirradiation | – | Radiation: ReirradiationAll patients treated with reirradiation with the aim of local control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- No guidelines are provided on the selection of patients for high dose reirradiation. All patients are eligible for the database if treated with reirradiation with the aim of local control.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reirradiationreirradiation with all available modalities can be included | Radiation | Reirradiation |
Primary outcome
Side effects
Time frame: 5 years
CTCAE side effects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided. A predefined central data analysis plan has not been established for this study. Instead, data analyses will primarily be undertaken within the framework of individual sub-projects, each of which must be reviewed and approved by the steering committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camilla JS Kronborg, PhD, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy Side Effect, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna R Mortensen, PhD, MD (92432382 ext. 22154394, hanna.mortensen@auh.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.