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
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
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
Single group
MRI-LINAC radiotherapy
RadiationStereotactic body radiotherapy (SBRT) is delivered using an MRI-guided linear accelerator (MR-LINAC), at a total dose of 60 Gy in 8 fractions (7.5 Gy per fraction) over 17 days. Treatment is performed using MR-guided adaptive radiotherapy with real-time imaging and respiratory motion management (gating).
Incidence of late treatment-related toxicity
Treatment-related toxicity is assessed according to NCI-CTCAE v6.0 and defined as grade ≥ 3 adverse events such as: pneumonitis, bronchopulmonary haemorrhage, fibrosis, airway obstruction, fistula, or oesophageal toxicity, or other severe toxicity. Death possibly related to radiotherapy within 36 months is also considered as an event.
Early and late adverse events (all grades)
Early and late adverse events are assessed according to NCI-CTCAE v6.0. Adverse events that are definitively linked to the underlying disease, the progression of the underlying disease, or systemic treatment are excluded.
Feasibility of MR-guided radiotherapy
Feasibility of MR-guided radiotherapy is evaluated considering occurrence of primary failures (patient who dindn't start treatment) or secondary failures (incomplete treatment, or significant interruption of more than one week).
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression (local, regional, or distant) or death from any cause
Overall Survival (OS)
Time from treatment initiation to death from any cause.
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Centre Oscar Lambret
Lead sponsor
Aquilab SAS
Collaborator
Centre François Baclesse (CTD-CNO)
Collaborator
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