Curatively Intended Thoracic Reirradiation

NCT06950073 | Recruiting

• 2 other identifiers: Curelung2025R374-A22286
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy Side Effect; Radiation Toxicity; Oncology; Lung Cancer; Thoracic Cancer

Keywords

Reirradiation; Aarhus; Denmark; Thoracic cancer; Lung Cancer; Oncology; Radiation Toxicity

Outcome Measures

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

  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

  From date of enrollment until the date of documented death

• Freedom from progressive disease

  From date of enrollment until the date of documented progression

• Patterns of failure

  From date of enrollment until the date of documented recurrence

• Acute radiotherapy-related toxicity grade 2 - 5

  Up to 6 months from the start of reirradiation

• Late radiotherapy-related toxicity grade 3 - 5

  From 6 months after the start of reirradiation and through study completion, assessed up to 60 months

Study Arms (1)

Patients with thoracic cancer elegible for reirradation.

Recurrent lung cancer, new primary lung cancer, solitary lung metastasis

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

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.

Patients with thoracic cancer elegible for reirradation.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Jutland, 8200, Denmark

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Radiation Injuries; Neoplasms; Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Stine O Fredslund, MD, PhD

CONTACT

+45 28713076; stin.fred@auh.rm.dk

Lone Hofmann, Physicist

CONTACT

+45 29939779; lone.hoffmann@aarhus.rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 29, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): May 1, 2035
• Last Updated: March 4, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)