Curatively Intended Thoracic Reirradiation
Recruiting · NCT06950073 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Aarhus University Hospital - Aarhus, Jutland, Denmark