Ultracentral Pulmonary TumorsLIN-LUNG-2504NCT07733219
Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy on Ultra-central Lung Tumors on MR-Linac
A study testing MRI-LINAC radiotherapy in people with Ultracentral Pulmonary Tumors and Lung Cancer (T1 N0 M0 and T2 N0 M0), run by Centre Oscar Lambret.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultracentral Pulmonary Tumors, Lung Cancer (T1 N0 M0 and T2 N0 M0), Mediastinal Lymph Node Recurrence From All Types of Primary Cancer
- What is being tested?
- MRI-LINAC radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year-old
- Clinical status:
- 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
- Metachronous oligoprogression: isolated metastatic recurrence in the mediastinal or ultra-central lung lymph nodes, with the primary tumour and metastatic sites under control (no change observed on two consecutive imaging scans and a complete metabolic response on PET) and not requiring continued treatment with chemotherapy or targeted therapy to ensure disease control (hormone therapy is, however, permitted)
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- Patient unsuitable for surgery, and treatment with stereotactic RT validated by multidisciplinary tumor board (including the radiation oncologist and medical physician)
- Ultracentral lesion defined by a GTV less than 1 cm of the PBT (proximal bronchial trachea, including the main bronchi, trachea and intermediate bronchi), oesophagus, or pericardum
- ECOG performance status ≤2 (for all patients)
- Patient covered by a health insurance system
- Patient agreed to take part in the study, and signed an informed consent form
- Use of a method of contraception (for female patients of childbearing age)
Who cannot join
- 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
- Contraindication to radiotherapy due to a comorbidity such as pulmonary fibrosis or scleroderma
- Respiratory contraindications (FEV1 < 20%)
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- Need of oncologic systemic treatment during RT
- Contraindication to MRI (e.g. severe claustrophobia unmanageable)
- Pregnancy or breastfeeding patient
- Patient under guardianship or curatorship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Florence LE TINIER, MD contact
About this study
Official title: Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy (SBRT) on Ultra-central Lung Tumors on MR-Linac (Magnetic Resonance Image-Guided Radiotherapy)
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
Read the detailed description
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.
- Conditions
- Ultracentral Pulmonary Tumors, Lung Cancer (T1 N0 M0 and T2 N0 M0), Mediastinal Lymph Node Recurrence From All Types of Primary Cancer, Pulmonary Node Recurrence From All Types of Primary Cancer
- Being tested
- MRI-LINAC radiotherapy
- Keywords
- Stereotactic body radiotherapy, MRI-LINAC, ultracentral lung tumors, toxicity, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-LINAC radiotherapyRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| MR-guided stereotactic radiotherapy (MR-LINAC) | Experimental | Not described Receives: Radiation: MRI-LINAC radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from 90 days post-radiotherapy to 36 months after end of treatment
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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
Measured: from treatment initiation to progression or death, assessed up to 36 months
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Measured: from treatment initiation up to 36 months
Local, regional, and distant disease control
Assessed using imaging-based evaluation and cumulative incidence of progression.
Measured: at 6, 12, 24, and 36 months after treatment
FEV1 lung test
This test evaluates forced expiratory volume in one second
Measured: 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.
Measured: 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.
Measured: 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
Measured: at baseline, and at 6, 18, and 30 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Nov 2031 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultracentral Pulmonary TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Aquilab SAS, Centre François Baclesse (CTD-CNO)
- Responsible party
- Sponsor
- Investigators
- Florence LE TINIER, MD, Study director, Centre Oscar Lambret, LilleDavid PASQUIER, MD, PhD, Study director, Centre Oscar Lambret, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733219
- Sponsor's protocol ID
- LIN-LUNG-2504
- Other IDs
- 2026-A00128-43
- Acronym
- LIN-LUNG-2504
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy (SBRT) on Ultra-central Lung Tumors on MR-Linac (Magnetic Resonance Image-Guided Radiotherapy)
- ClinicalTrials.gov ID
- NCT07733219
- Acronym / sponsor ID
- LIN-LUNG-2504 / LIN-LUNG-2504
- Conditions
- Ultracentral Pulmonary Tumors, Lung Cancer (T1 N0 M0 and T2 N0 M0), Mediastinal Lymph Node Recurrence From All Types of Primary Cancer, Pulmonary Node Recurrence From All Types of Primary Cancer
- Keywords
- Stereotactic body radiotherapy, MRI-LINAC, ultracentral lung tumors, toxicity, lung cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Aquilab SAS, Centre François Baclesse (CTD-CNO)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Nov 2031 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-guided stereotactic radiotherapy (MR-LINAC) | Experimental | Radiation: MRI-LINAC radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 year-old
- Clinical status:
- Patient unsuitable for surgery, and treatment with stereotactic RT validated by multidisciplinary tumor board (including the radiation oncologist and medical physician)
- Ultracentral lesion defined by a GTV less than 1 cm of the PBT (proximal bronchial trachea, including the main bronchi, trachea and intermediate bronchi), oesophagus, or pericardum
- ECOG performance status ≤2 (for all patients)
Key exclusion criteria (10 listed)
- 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
- Contraindication to radiotherapy due to a comorbidity such as pulmonary fibrosis or scleroderma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-LINAC radiotherapyStereotactic 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). | Radiation | MR-guided stereotactic radiotherapy (MR-LINAC) |
Primary outcome
Incidence of late treatment-related toxicity
Time frame: from 90 days post-radiotherapy to 36 months after end of treatment
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.
9 secondary outcomes
Early and late adverse events (all grades)
Time frame: From radiotherapy simulation up to 36 months post-radiotherapy
Feasibility of MR-guided radiotherapy
Time frame: from treatment initiation up to 3 months after completion of radiotherapy
Progression-Free Survival (PFS)
Time frame: from treatment initiation to progression or death, assessed up to 36 months
Overall Survival (OS)
Time frame: from treatment initiation up to 36 months
Local, regional, and distant disease control
Time frame: at 6, 12, 24, and 36 months after treatment
FEV1 lung test
Time frame: at baseline, and at 6, 18, and 30 months post-treatment
Dosimetric parameters related to target coverage (GTV, CTV, PTV)
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
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)
Time frame: at baseline, and at 6, 18, and 30 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florence LE TINIER, MD contact
Florence LE TINIER, MD study director
Centre Oscar Lambret, Lille
David PASQUIER, MD, PhD study director
Centre Oscar Lambret, Lille
Questions about this trial
What is this clinical trial studying?
A study testing MRI-LINAC radiotherapy in people with Ultracentral Pulmonary Tumors and Lung Cancer (T1 N0 M0 and T2 N0 M0), run by Centre Oscar Lambret.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicia PROBST, PhD (+33 (0)3 20 29 59 18, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of late treatment-related toxicity (time frame: from 90 days post-radiotherapy to 36 months after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.