Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy on Ultra-central Lung Tumors on MR-Linac (LIN-LUNG-2504)
28 luglio 2026 aggiornato da: Centre Oscar Lambret
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
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
59
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Florence LE TINIER, MD
Backup dei contatti dello studio
- Nome: Alicia PROBST, PhD
- Numero di telefono: +33 (0)3 20 29 59 18
- Email: promotion@o-lambret.fr
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- 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)
- 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)
Exclusion Criteria:
- 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%)
- Need of oncologic systemic treatment during RT
- Contraindication to MRI (e.g. severe claustrophobia unmanageable)
- Pregnancy or breastfeeding patient
- Patient under guardianship or curatorship
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: MR-guided stereotactic radiotherapy (MR-LINAC)
|
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).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of late treatment-related toxicity
Lasso di tempo: 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. |
from 90 days post-radiotherapy to 36 months after end of treatment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Early and late adverse events (all grades)
Lasso di tempo: From radiotherapy simulation up to 36 months post-radiotherapy
|
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.
|
From radiotherapy simulation up to 36 months post-radiotherapy
|
|
Feasibility of MR-guided radiotherapy
Lasso di tempo: from treatment initiation up to 3 months after completion of 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).
|
from treatment initiation up to 3 months after completion of radiotherapy
|
|
Progression-Free Survival (PFS)
Lasso di tempo: from treatment initiation to progression or death, assessed up to 36 months
|
Time from treatment initiation to disease progression (local, regional, or distant) or death from any cause
|
from treatment initiation to progression or death, assessed up to 36 months
|
|
Overall Survival (OS)
Lasso di tempo: from treatment initiation up to 36 months
|
Time from treatment initiation to death from any cause.
|
from treatment initiation up to 36 months
|
|
Local, regional, and distant disease control
Lasso di tempo: at 6, 12, 24, and 36 months after treatment
|
Assessed using imaging-based evaluation and cumulative incidence of progression.
|
at 6, 12, 24, and 36 months after treatment
|
|
FEV1 lung test
Lasso di tempo: at baseline, and at 6, 18, and 30 months post-treatment
|
This test evaluates forced expiratory volume in one second
|
at baseline, and at 6, 18, and 30 months post-treatment
|
|
Dosimetric parameters related to target coverage (GTV, CTV, PTV)
Lasso di tempo: 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. .
|
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.
|
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
Lasso di tempo: 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.
|
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.
|
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)
Lasso di tempo: at baseline, and at 6, 18, and 30 months post-treatment
|
The DLCO test measures how effectively the lungs transfer oxygen from inhaled air to the blood
|
at baseline, and at 6, 18, and 30 months post-treatment
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Florence LE TINIER, MD, Centre Oscar Lambret, Lille
- Direttore dello studio: David PASQUIER, MD, PhD, Centre Oscar Lambret, Lille
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 novembre 2031
Completamento dello studio (Stimato)
1 novembre 2031
Date di iscrizione allo studio
Primo inviato
29 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 luglio 2026
Primo Inserito (Effettivo)
29 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LIN-LUNG-2504
- 2026-A00128-43 (Altro identificatore: IDRCB)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .