NCT07528339

Brief 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 larger group of patients. To build a reirradiation cohort database for future research

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
131mo left

Started Apr 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Mar 2037

Study Start

First participant enrolled

April 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2032

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2037

Last Updated

April 14, 2026

Status Verified

February 1, 2026

Enrollment Period

6 years

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Side effects

    CTCAE side effects

    5 years

Study Arms (1)

Reirradiation

All patients treated with reirradiation with the aim of local control

Radiation: Reirradiation

Interventions

ReirradiationRADIATION

reirradiation with all available modalities can be included

Reirradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiation Injuries

Interventions

Re-Irradiation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsRetreatment

Central Study Contacts

Hanna R Mortensen, PhD, MD

CONTACT

Camilla JS Kronborg, PhD, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2032

Study Completion (Estimated)

March 31, 2037

Last Updated

April 14, 2026

Record last verified: 2026-02