NCT06950073 Curatively Intended Thoracic Reirradiation
| NCT ID | NCT06950073 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Radiotherapy Side Effect |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-10-10 |
| Primary Completion | 2035-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-10-10 with a primary completion date of 2035-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06950073 clinical trial?
This trial is open to participants of all sexes, studying Radiotherapy Side Effect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06950073 currently recruiting?
Yes, NCT06950073 is actively recruiting participants. Contact the research team at stin.fred@auh.rm.dk for enrollment information.
Where is the NCT06950073 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06950073 clinical trial?
NCT06950073 is sponsored by University of Aarhus. The trial plans to enroll 500 participants.