Clinical trial · Observational
Curatively Intended Thoracic Reirradiation
CUratively Intended Thoracic REirradiation: An Observational Study of High-dose Reirradiation of Thoracic Tumours: A Multicentre Prospective Registration Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Oncology | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with thoracic cancer elegible for reirradation.
- description
- Recurrent lung cancer, new primary lung cancer, solitary lung metastasis
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Toxicity grade 4-5
- timeFrame
- 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 months
- description
- Radiotherapy-related toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) grade 4 - 5 one year after start of radiotherapy
Secondary outcomes (9)
- measure
- Overall survival
- timeFrame
- From date of enrollment until the date of documented death
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (18)
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDAbusaris H, Storchi PR, Brandwijk RP, Nuyttens JJ. Second re-irradiation: efficacy, dose and toxicity in patients who received three courses of radiotherapy with overlapping fields. Radiother Oncol. 2011 May;99(2):235-9. doi: 10.1016/j.radonc.2011.03.010. Epub 2011 Apr 15. PMID 21497928
- BACKGROUNDAmini A, Yang J, Williamson R, McBurney ML, Erasmus J Jr, Allen PK, Karhade M, Komaki R, Liao Z, Gomez D, Cox J, Dong L, Welsh J. Dose constraints to prevent radiation-induced brachial plexopathy in patients treated for lung cancer. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e391-8. doi: 10.1016/j.ijrobp.2011.06.1961. PMID 22284035
- BACKGROUNDAndratschke N, Willmann J, Appelt AL, Alyamani N, Balermpas P, Baumert BG, Hurkmans C, Hoyer M, Langendijk JA, Kaidar-Person O, van der Linden Y, Meattini I, Niyazi M, Reynaert N, De Ruysscher D, Tanadini-Lang S, Hoskin P, Poortmans P, Nieder C. European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus on re-irradiation: definition, reporting, and clinical decision making. Lancet Oncol. 2022 Oct;23(10):e469-e478. doi: 10.1016/S1470-2045(22)00447-8. PMID 36174633
- BACKGROUNDAng KK, Price RE, Stephens LC, Jiang GL, Feng Y, Schultheiss TE, Peters LJ. The tolerance of primate spinal cord to re-irradiation. Int J Radiat Oncol Biol Phys. 1993 Feb 15;25(3):459-64. doi: 10.1016/0360-3016(93)90067-6. PMID 8436524
- BACKGROUNDAng KK, Jiang GL, Feng Y, Stephens LC, Tucker SL, Price RE. Extent and kinetics of recovery of occult spinal cord injury. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):1013-20. doi: 10.1016/s0360-3016(01)01599-1.