Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy on Ultra-central Lung Tumors on MR-Linac

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Oscar Lambret

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

59 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Centre Oscar Lambret

Lead sponsor

Aquilab SAS

Collaborator

Centre François Baclesse (CTD-CNO)

Collaborator