About this trial
Phase II multicenter trial evaluating the safety, tolerability, and feasibility of MRI-guided stereotactic radiotherapy using MRI-LINAC in patients with ultracentral lung tumors or lymphadenopathy in the context of controlled oligometastatic disease. The study investigates the potential of this innovative technology, which enables real-time treatment adaptation, with the goal of optimizing the benefit-risk ratio in a population at high risk of radiotherapy-related toxicity
Eligibility criteria
Qualifiers
Age ≥ 18 year-old
Primary lung tumour T1-T2 N0, confirmed histologically by bronchoscopic examination, or meeting the criteria set out in the Aura 2026 and ASTRO guidelines for the indication of stereotactic radiotherapy (tumor growth of at least 2 mm between two CT scans performed 3 months apart, metabolic hyper-intensity on PET, and no pathological evidence), OR
Metachronous oligometastatic disease: isolated mediastinal or non-central pulmonary lymph node recurrence occurring sometimes after initial cancer treatments for an initially localised, locally advanced or oligometastatic cancer that has been treated OR
Synchronous oligometastatic disease: all metastatic sites and the primary tumour must be amenable to local debulking treatment following systemic treatment. Systemic treatment (chemotherapy or targeted therapy) must not be administered concurrently with radiotherapy OR
Disqualifiers
Tumour with intrabronchial or intratracheal invasion identified by fibroscopy, bronchoscopy or localisation MRI
Prior RT overlapping the intended treatment field
Patients with oligoprogression requiring continued systemic treatment during RT
Uncontrolled intercurrent diseases
Trial design
Treatments tested in this trial
- MRI-LINAC radiotherapy
Treatment groups
Locations
Sponsors and collaborators
Centre Oscar Lambret
Lead sponsor
Aquilab SAS
Collaborator
Centre François Baclesse (CTD-CNO)
Collaborator