Radiotherapy Side EffectCureLungNCT06950073
Curatively Intended Thoracic Reirradiation
An observational study of Radiotherapy Side Effect and Radiation Toxicity, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiotherapy Side Effect, Radiation Toxicity, Oncology
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2025to 1 May 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Show all 10Show fewer
- ECOG Performance status 0-2.
- Estimated life expectancy ≥ 6 months
- Age ≥18 years
- Signed informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Jutland, 8200
About this study
Official title: CUratively Intended Thoracic REirradiation: An Observational Study of High-dose Reirradiation of Thoracic Tumours: A Multicentre Prospective Registration Protocol
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.
Read more
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.
Read the detailed description
- BACKGROUND: The number of long-term survivors is increasing for thoracic cancers, however, a significant proportion of lung cancer (LC) patients treated with curatively intended radiotherapy (RT) may experience locoregional recurrence or develop a new cancer. This highlights the need for effective local treatment options. Repeated high-dose RT (reRT) is a promising approach gaining traction in clinical practice. At Aarhus University Hospital (AUH), the fraction of LC patients offered curative reRT has increased from 4% in 2015 to 13% in 2024. The overall survival (OS) of reirradiated recurrent or new LC range from 7-14 months (from time of reirradiation) and depends on a variety of parameters, including tumour dose and PTV volume. ReRT has been linked to high rates of severe toxicity, leading to some patients not being offered curative reRT. Establishing solid evidence of the risks associated with reRT is crucial to offering these patients reRT on an equal footing with patients treated for their first cancer. Former studies on reRT of LC include a median of 40 (maximum 102) patients16, with diverse results on OS and no clear correlations between toxicity risk and cumulative (summed) RT doses.
- AIM: Establish a framework for LC reRT based on data from CURE Lung to support clinical and shared decision-making (SDM). Four sub-studies obtain this: 2.1 Establish a national infrastructure for reRT and implement decision-making tools to guide patient referrals to specialised modalities like proton therapy and MR-linac, ensuring optimal treatment modality selection to reRT for the individual patient. 2.2 Integrate and analyse Patient Reported Outcome Measures (PROM), Quality of Life (QoL), and decision regret data in CURE Lung. Mapping of the patient's self-reported symptoms and correlation to toxicity data ensures an optimal overview of total disease burden and informs which patients are candidates for reRT. 2.3 Establish and evaluate SDM focusing on the clinical risk assessment and the patient's wishes as tools for optimal patient involvement. SDM will improve the participants' knowledge, and accuracy of risk perceptions, and help them choose the best treatment, minimizing regret and improving QoL. 2.4 Build models correlating patient- and physician-reported toxicity to RT doses, considering prior treatments, co-morbidity, and QoL to inform decision-making. This will provide dose limits for reRT, allowing individualised dose prescriptions based on toxicity risk, comorbidities and prior treatments.
- HYPOTHESES: Primary hypothesis:
- Cumulative radiation dose is related to radiotherapy-related toxicity for patients undergoing thoracic reirradiation Secondary hypothesis:
- Curative reirradiation is feasible and safe for a selected patient cohort when delivered based on strict dose limits
- PATIENTS: Recurrent or new LC, or solitary oligo lung metastases. The investigators 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 AND DATA COLLECTION: This is a multicentre prospective registration protocol. The trial is based on a high mandatory standard being mandatory for participation with 1) 3D dose summation, 2) data on previous RT, systemic treatments, surgery, comorbidity and G3-4 thoracic toxicity collected at baseline, 3) prospective clinical follow-up with G2-5 toxicity scoring, and thoracic CT-imaging, performed every three months until two years and bi-annually until five years enabling reliable longitudinal toxicity scoring, and 4) pre-trial QA consisting of image registration, treatment planning and healthy tissue delineation. Toxicity and patient-reported outcomes (PROM) will be monitored during and up to 5 years after treatment using common terminology criteria for adverse events (CTCAE) and the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaires (QLQ-C30 and LC13). Central databases will be used for clinical (Redcap) and dosimetric (dcmcollab) data collection.
- PERSPECTIVES:
The CURE Lung trial will yield internationally high-impact results. The trial is based on state-of-the-art treatment delivery, dose accumulation, and clinical data collection, ensuring exceptional data quality for modelling studies. The trial data will be unique in patient numbers and data quality. Similar data are not available Worldwide. The current project will ensure full utilisation of and learning from the trial, adding SDM, PROMs, referral to specialised modalities, and high-level QA to the trial. It will enable modelling the correlation between toxicity burden and individual patient doses, paving the way for individualised reRT with optimised 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.
Results will be published in scientific international journals (Radiother Oncol, Int J Radiat Oncol Biol Phys, J Clin Oncol, and J Thorac Oncol), and presented at international conferences and Danske Kræftforskningsdage.
The findings may apply to reRT for other cancers, benefitting all Danish patients. The project underpins the new work package for reRT under the Danish Comprehensive Cancer Center for RT (DCCC-RT), aiming to collect and standardize national reRT data.
- Being tested
- Radiotherapy
- Keywords
- Reirradiation, Aarhus, Denmark, Thoracic cancer, Lung Cancer, Oncology, Radiation Toxicity
- Medical subject headings
- Radiation Injuries, Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with thoracic cancer elegible for reirradation. | Recurrent lung cancer, new primary lung cancer, solitary lung metastasis Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Secondary outcomes (9)
Overall survival
The length of time from the start of radiotherapy, that patients are still alive.
Measured: From date of enrollment until the date of documented death
Freedom from progressive disease
The length of time from the start of radiotherapy, that a patient lives with the disease without it getting worse
Measured: From date of enrollment until the date of documented progression
Patterns of failure
If recurrence is diagnosed, where have the disease reappeared?
Measured: From date of enrollment until the date of documented recurrence
Acute radiotherapy-related toxicity grade 2 - 5
Using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade 2 - 5
Measured: Up to 6 months from the start of reirradiation
Late radiotherapy-related toxicity grade 3 - 5
Using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade 3-5
Measured: From 6 months after the start of reirradiation and through study completion, assessed up to 60 months
Radiotherapy treatment compliance
The extent to which a person's behavior follows medical advice or corresponds with recommendations from the health care provider.
Measured: Through study completion, assessed up to 60 months
Quality of Life (QoL)
The European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaires C30 (general module) and LC13 (lung cancer-specific module) will be used to evaluate QoL and symptoms.
Measured: Baseline, at 3 months, and each year through study completion
Patient reported outcome measures (PROM)
The EuroQol 5-level EQ-5D version (EQ-5D-5L) questionnaire will be used to describe the health state of the patients.
Measured: Baseline, at 3 months, and each year through study completion
Decision regret according to the Ottawa Hospital scale
Decision regret is a negative emotion involving distress or remorse following a decision related to the treatment
Measured: Baseline, at 3 months, and each year through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start10 Oct 2025
- Primary completion1 May 2035 (estimated)
- Study completion1 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950073
- Sponsor's protocol ID
- Curelung2025
- Other IDs
- R374-A22286
- Acronym
- CureLung
- Status last verified
- Mar 2025
- First submitted
- 14 Apr 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aaronson 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.
PubMed 8433390Abusaris 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.
PubMed 21497928Amini 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.
PubMed 22284035Andratschke 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.
PubMed 36174633Ang 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.
PubMed 8436524Ang 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.
PubMed 11429229Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
PubMed 28885881Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.
PubMed 30280658Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.
PubMed 20351327Badiyan SN, Rutenberg MS, Hoppe BS, Mohindra P, Larson G, Hartsell WF, Tsai H, Zeng J, Rengan R, Glass E, Katz S, Vargas C, Feigenberg SJ, Simone CB 2nd. Clinical Outcomes of Patients With Recurrent Lung Cancer Reirradiated With Proton Therapy on the Proton Collaborative Group and University of Florida Proton Therapy Institute Prospective Registry Studies. Pract Radiat Oncol. 2019 Jul-Aug;9(4):280-288. doi: 10.1016/j.prro.2019.02.008. Epub 2019 Feb 23.
PubMed 30802618Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.
PubMed 17081915Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010 Mar 11;362(10):865-9. doi: 10.1056/NEJMp0911494. No abstract available.
PubMed 20220181Becerra Perez MM, Menear M, Brehaut JC, Legare F. Extent and Predictors of Decision Regret about Health Care Decisions: A Systematic Review. Med Decis Making. 2016 Aug;36(6):777-90. doi: 10.1177/0272989X16636113. Epub 2016 Mar 14.
PubMed 26975351Bellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.
PubMed 22250183Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer. 1994;30A(5):635-42. doi: 10.1016/0959-8049(94)90535-5.
PubMed 8080679
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CUratively Intended Thoracic REirradiation: An Observational Study of High-dose Reirradiation of Thoracic Tumours: A Multicentre Prospective Registration Protocol
- ClinicalTrials.gov ID
- NCT06950073
- Acronym / sponsor ID
- CureLung / Curelung2025
- Keywords
- Reirradiation, Aarhus, Denmark, Thoracic cancer, Lung Cancer, Oncology, Radiation Toxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 May 2035 (estimated)
- Study completion
- 1 May 2035 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- BACKGROUND: The number of long-term survivors is increasing for thoracic cancers, however, a significant proportion of lung cancer (LC) patients treated with curatively intended radiotherapy (RT) may experience locoregional recurrence or develop a new cancer. This highlights the need for effective local treatment options. Repeated high-dose RT (reRT) is a promising approach gaining traction in clinical practice. At Aarhus University Hospital (AUH), the fraction of LC patients offered curative reRT has increased from 4% in 2015 to 13% in 2024. The overall survival (OS) of reirradiated recurrent or new LC range from 7-14 months (from time of reirradiation) and depends on a variety of parameters, including tumour dose and PTV volume. ReRT has been linked to high rates of severe toxicity, leading to some patients not being offered curative reRT. Establishing solid evidence of the risks associated with reRT is crucial to offering these patients reRT on an equal footing with patients treated for their first cancer. Former studies on reRT of LC include a median of 40 (maximum 102) patients16, with diverse results on OS and no clear correlations between toxicity risk and cumulative (summed) RT doses.
- AIM: Establish a framework for LC reRT based on data from CURE Lung to support clinical and shared decision-making (SDM). Four sub-studies obtain this: 2.1 Establish a national infrastructure for reRT and implement decision-making tools to guide patient referrals to specialised modalities like proton therapy and MR-linac, ensuring optimal treatment modality selection to reRT for the individual patient. 2.2 Integrate and analyse Patient Reported Outcome Measures (PROM), Quality of Life (QoL), and decision regret data in CURE Lung. Mapping of the patient's self-reported symptoms and correlation to toxicity data ensures an optimal overview of total disease burden and informs which patients are candidates for reRT. 2.3 Establish and evaluate SDM focusing on the clinical risk assessment and the patient's wishes as tools for optimal patient involvement. SDM will improve the participants' knowledge, and accuracy of risk perceptions, and help them choose the best treatment, minimizing regret and improving QoL. 2.4 Build models correlating patient- and physician-reported toxicity to RT doses, considering prior treatments, co-morbidity, and QoL to inform decision-making. This will provide dose limits for reRT, allowing individualised dose prescriptions based on toxicity risk, comorbidities and prior treatments.
- HYPOTHESES: Primary hypothesis:
- Cumulative radiation dose is related to radiotherapy-related toxicity for patients undergoing thoracic reirradiation Secondary hypothesis:
- Curative reirradiation is feasible and safe for a selected patient cohort when delivered based on strict dose limits
- PATIENTS: Recurrent or new LC, or solitary oligo lung metastases. The investigators 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 AND DATA COLLECTION: This is a multicentre prospective registration protocol. The trial is based on a high mandatory standard being mandatory for participation with 1) 3D dose summation, 2) data on previous RT, systemic treatments, surgery, comorbidity and G3-4 thoracic toxicity collected at baseline, 3) prospective clinical follow-up with G2-5 toxicity scoring, and thoracic CT-imaging, performed every three months until two years and bi-annually until five years enabling reliable longitudinal toxicity scoring, and 4) pre-trial QA consisting of image registration, treatment planning and healthy tissue delineation. Toxicity and patient-reported outcomes (PROM) will be monitored during and up to 5 years after treatment using common terminology criteria for adverse events (CTCAE) and the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaires (QLQ-C30 and LC13). Central databases will be used for clinical (Redcap) and dosimetric (dcmcollab) data collection.
- PERSPECTIVES:
The CURE Lung trial will yield internationally high-impact results. The trial is based on state-of-the-art treatment delivery, dose accumulation, and clinical data collection, ensuring exceptional data quality for modelling studies. The trial data will be unique in patient numbers and data quality. Similar data are not available Worldwide. The current project will ensure full utilisation of and learning from the trial, adding SDM, PROMs, referral to specialised modalities, and high-level QA to the trial. It will enable modelling the correlation between toxicity burden and individual patient doses, paving the way for individualised reRT with optimised 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.
Results will be published in scientific international journals (Radiother Oncol, Int J Radiat Oncol Biol Phys, J Clin Oncol, and J Thorac Oncol), and presented at international conferences and Danske Kræftforskningsdage.
The findings may apply to reRT for other cancers, benefitting all Danish patients. The project underpins the new work package for reRT under the Danish Comprehensive Cancer Center for RT (DCCC-RT), aiming to collect and standardize national reRT data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with thoracic cancer elegible for reirradation. | – | Radiation: RadiotherapyRecurrent lung cancer, new primary lung cancer, solitary lung metastasis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy 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. | Radiation | Patients with thoracic cancer elegible for reirradation. |
Primary outcome
Toxicity grade 4-5
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 months
Radiotherapy-related toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) grade 4 - 5 one year after start of radiotherapy
9 secondary outcomes
Overall survival
Time frame: From date of enrollment until the date of documented death
Freedom from progressive disease
Time frame: From date of enrollment until the date of documented progression
Patterns of failure
Time frame: From date of enrollment until the date of documented recurrence
Acute radiotherapy-related toxicity grade 2 - 5
Time frame: Up to 6 months from the start of reirradiation
Late radiotherapy-related toxicity grade 3 - 5
Time frame: From 6 months after the start of reirradiation and through study completion, assessed up to 60 months
Radiotherapy treatment compliance
Time frame: Through study completion, assessed up to 60 months
Quality of Life (QoL)
Time frame: Baseline, at 3 months, and each year through study completion
Patient reported outcome measures (PROM)
Time frame: Baseline, at 3 months, and each year through study completion
Decision regret according to the Ottawa Hospital scale
Time frame: Baseline, at 3 months, and each year through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 8433390Aaronson 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.
- Background: PubMed 21497928Abusaris 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.
- Background: PubMed 22284035Amini 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.
- Background: PubMed 36174633Andratschke 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.
- Background: PubMed 8436524Ang 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.
- Background: PubMed 11429229Ang 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.
- Background: PubMed 28885881Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
- Background: PubMed 30280658Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.
- Background: PubMed 20351327Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.
- Background: PubMed 30802618Badiyan SN, Rutenberg MS, Hoppe BS, Mohindra P, Larson G, Hartsell WF, Tsai H, Zeng J, Rengan R, Glass E, Katz S, Vargas C, Feigenberg SJ, Simone CB 2nd. Clinical Outcomes of Patients With Recurrent Lung Cancer Reirradiated With Proton Therapy on the Proton Collaborative Group and University of Florida Proton Therapy Institute Prospective Registry Studies. Pract Radiat Oncol. 2019 Jul-Aug;9(4):280-288. doi: 10.1016/j.prro.2019.02.008. Epub 2019 Feb 23.
- Background: PubMed 17081915Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.
- Background: PubMed 20220181Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010 Mar 11;362(10):865-9. doi: 10.1056/NEJMp0911494. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy Side Effect and Radiation Toxicity, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stine O Fredslund, MD, PhD (+45 28713076, stin.fred@auh.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity grade 4-5 (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 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06950073, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.