Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK)

N/ANot Yet RecruitingNCT07528339

University of Aarhus500 enrolled

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

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Radiotherapy Side Effect

Interventions

ReirradiationRADIATION

reirradiation with all available modalities can be included

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Side effects

CTCAE side effects

Time frame: 5 years

Central Contacts

Hanna R Mortensen, PhD, MD

CONTACT

92432382 hanna.mortensen@auh.rm.dk

Camilla JS Kronborg, PhD, MD

CONTACT

cam.kro@auh.rm.dk

Data from ClinicalTrials.gov

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