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CUratively Intended Thoracic REirradiation: An Observational Study of High-dose Reirradiation of Thoracic Tumours: A Multicentre Prospective Registration Protocol

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

The number of long-term lung cancer (LC) survivors increases, however many patients are diagnosed with recurrent or new thoracic cancers. High-dose reirradiation (reRT) is promising but associated with high severe toxicity rates. Existing studies are small lacking high-quality data, with no clear correlation between toxicity risk and delivered radiotherapy (RT) dose. This Danish multicentre prospective cohort study aims to provide a framework for collecting radiotherapy-related toxicity data, loco-regional control, and overall survival data for patients with thoracic cancer undergoing reirradiation; with the ultimate aim of providing safe reirradiation to more patients. As a secondary aim, guidelines for dose accumulation and provisional constraints for the organs at risk will be used to establish a uniform treatment strategy for reirradiation. The CURE Lung trial will provide high-impact, globally missing data. This project will ensure full utilization of and learning from the trial, adding SDM, PROMs, and modality referral to the trial. It will model the correlation between toxicity burden and doses, enabling individualized reRT with optimized dose prescription based on toxicity risk and patient preferences, and assisting in the decision-making on the prescription dose and optimal modality. This will ensure safe reRT for the increasing number of long-term LC survivors.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Radiotherapy of thoracic lesion(s) (loco-regional lung cancer recurrence, new primary lung cancer, or solitary oligo metastasis) with the aim of long-term local control.

• Reirradiation type 1 or type 2, i.e. previous radiotherapy to the thorax as per ESTRO-EORTC consensus definition of reirradiation \[Andratschke 2022\]. For the sake of this study, multiple treatments to the lungs will be classified as type 2 reirradiation.

• Verification of malignancy based on biopsy. If no biopsy is available, the decision of reirradiation should be agreed upon in a multidisciplinary conference.

• Available digital dose plan(s) from former radiotherapy course(s) (DICOM files) - note that multiple re-treatments are allowed.

• Adequate lung function to tolerate treatment, at the discretion of the treating physician.

• Ability to complete a radiotherapy course with the aim of local control.

• ECOG Performance status 0-2.

• Estimated life expectancy ≥ 6 months

• Age ≥18 years

• Signed informed consent

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Stine O Fredslund, MD, PhD
stin.fred@auh.rm.dk
+45 28713076
Backup
Lone Hofmann, Physicist
lone.hoffmann@aarhus.rm.dk
+45 29939779
Time Frame
Start Date: 2025-10-10
Estimated Completion Date: 2035-05-01
Participants
Target number of participants: 500
Treatments
Patients with thoracic cancer elegible for reirradation.
Recurrent lung cancer, new primary lung cancer, solitary lung metastasis
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov