Curatively Intended Thoracic Reirradiation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Aarhus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Uncontrolled other malignancy.
The primary and the reirradiation treatment may not be quasi-simultaneous (i.e. the two treatments should be planned independently)
Pregnancy
Radiotherapy to a minimum CTV mean dose of 45 Gy for SCLC and 50 Gy for NSCLC and oligometastatic lesions. Treatment schedule according to local protocols and treating physician preference.
Trial population
Recurrent or new LC, or solitary oligo lung metastases. We plan for 500 patients in 3-4 years. Annually, approximately 100-150 patients are expected from the seven Danish RT centres based on a recent comprehensive national audit of RT retreatment numbers and sites.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Radiotherapy
RadiationRadiotherapy is offered in the same dose to all patients eligible to reirradiation no matter if they are enrolled in the study or not. Meaning no intervention is done. This is a registration study.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Patients with thoracic cancer elegible for reirradation.1 intervention
Trial outcomes
Primary outcomes
1
Toxicity grade 4-5
Radiotherapy-related toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) grade 4 - 5 one year after start of radiotherapy
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsSecondary outcomes
1
Overall survival
The length of time from the start of radiotherapy, that patients are still alive.
Time frame
From date of enrollment until the date of documented death2
Freedom from progressive disease
The length of time from the start of radiotherapy, that a patient lives with the disease without it getting worse
Time frame
From date of enrollment until the date of documented progression3
Patterns of failure
If recurrence is diagnosed, where have the disease reappeared?
Time frame
From date of enrollment until the date of documented recurrence4
Acute radiotherapy-related toxicity grade 2 - 5
Using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade 2 - 5
Time frame
Up to 6 months from the start of reirradiationSponsors and contacts
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Source ClinicalTrials.gov