An interventional study of MRI-LINAC radiotherapy in Ultracentral Pulmonary Tumors, Lung Cancer (T1 N0 M0 and T2 N0 M0) and Mediastinal Lymph Node Recurrence From All Types of Primary Cancer, sponsored by Centre Oscar Lambret. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Centre Oscar Lambret · Not applicable, Interventional, and Treatment
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
This interventional, prospective, multicenter, non-randomized Phase II study primarily aims to evaluate the safety of MRI-guided stereotactic radiotherapy delivered with an MRI-LINAC, particularly in terms of late toxicity of grade ≥3.
Ultracentral lung tumors represent a major therapeutic challenge due to their immediate proximity to critical structures such as the tracheobronchial tree, oesophagus, and pericardium. This location exposes patients to an increased risk of severe complications (haemorrhage, fistula, stenosis, pneumonitis), limiting the doses that can be delivered with conventional radiotherapy and potentially compromising tumor control.
The use of an MRI-LINAC enables real-time visualization of anatomical structures and adaptation of the treatment plan at each session (adaptive radiotherapy). This technology also incorporates respiratory motion management systems (gating), allowing for reduced treatment margins and improved sparing of organs at risk.
Enrolled patients will receive stereotactic radiotherapy delivered in 8 fractions, with extended clinical, radiological, and functional follow-up.
In addition to assessing late toxicity, the study will also evaluate the feasibility of the technique, early adverse events, overall survival, progression-free survival, tumor control, and changes in respiratory function.
The overall objective is to demonstrate that MRI-LINAC-guided radiotherapy can reduce toxicity while maintaining satisfactory tumor control in this high-risk population, thereby improving the management of ultracentral lung tumors.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 59 is close to the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Centre Oscar Lambret is the lead sponsor of 130 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical status:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiation: MRI-LINAC radiotherapy
Stereotactic 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.
Time frame: from 90 days post-radiotherapy to 36 months after end of treatment
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.
Time frame: From radiotherapy simulation up to 36 months post-radiotherapy
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).
Time frame: from treatment initiation up to 3 months after completion of radiotherapy
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression (local, regional, or distant) or death from any cause
Time frame: from treatment initiation to progression or death, assessed up to 36 months
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Time frame: from treatment initiation up to 36 months
Local, regional, and distant disease control
Assessed using imaging-based evaluation and cumulative incidence of progression.
Time frame: at 6, 12, 24, and 36 months after treatment
FEV1 lung test
This test evaluates forced expiratory volume in one second
Time frame: at baseline, and at 6, 18, and 30 months post-treatment
Dosimetric parameters related to target coverage (GTV, CTV, PTV)
Gross Tumor Volume (GTV), Clinical Target Volume (CTV), and Planning Target Volume (PTV) are evaluated, and recorded during treatment planning, and at each adaptive fraction to document the benefit of online plan adaptation enabled by the MR-LINAC technology.
Time frame: During treatment planning (less than 30 days after enrollment), and then at each radiotherapy session (8 sessions spaced 2 days apart over a period of 17 days). Radiotherapy should start no later than 30 days after enrollment. .
Radiation dose delivered to CTV and OAR
The radiation dose delivered (Gy) to the clinical target volume (CTV) and healthy nearby tissues (OAR, Organs at Risk) is evaluated, and recorded during treatment planning, and at each adaptive fraction, to document the benefit of online plan adaptation enabled by the MR-LINAC technology.
Time frame: During treatment planning (less than 30 days after enrollment), and then at each radiotherapy session (8 sessions spaced 2 days apart over a period of 17 days). Radiotherapy should start no later than 30 days after enrollment.
Lung diffusion test (DLCO)
The DLCO test measures how effectively the lungs transfer oxygen from inhaled air to the blood
Time frame: at baseline, and at 6, 18, and 30 months post-treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Nov 2031, 62 months later.
Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 62 months is above that.
Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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