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Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy on Ultra-central Lung Tumors on MR-Linac (LIN-LUNG-2504)

28. července 2026 aktualizováno: 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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

59

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Florence LE TINIER, MD

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Age ≥ 18 year-old

  2. Clinical status:

    1. 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
    2. 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
    3. 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
    4. 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)
  3. Patient unsuitable for surgery, and treatment with stereotactic RT validated by multidisciplinary tumor board (including the radiation oncologist and medical physician)
  4. 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
  5. ECOG performance status ≤2 (for all patients)
  6. Patient covered by a health insurance system
  7. Patient agreed to take part in the study, and signed an informed consent form
  8. Use of a method of contraception (for female patients of childbearing age)

Exclusion Criteria:

  1. Tumour with intrabronchial or intratracheal invasion identified by fibroscopy, bronchoscopy or localisation MRI
  2. Prior RT overlapping the intended treatment field
  3. Patients with oligoprogression requiring continued systemic treatment during RT
  4. Uncontrolled intercurrent diseases
  5. Contraindication to radiotherapy due to a comorbidity such as pulmonary fibrosis or scleroderma
  6. Respiratory contraindications (FEV1 < 20%)
  7. Need of oncologic systemic treatment during RT
  8. Contraindication to MRI (e.g. severe claustrophobia unmanageable)
  9. Pregnancy or breastfeeding patient
  10. Patient under guardianship or curatorship

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: MR-guided stereotactic radiotherapy (MR-LINAC)
Záření: 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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of late treatment-related toxicity
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Early and late adverse events (all grades)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Centre Oscar Lambret

Spolupracovníci

Aquilab SAS
Centre François Baclesse (CTD-CNO)

Vyšetřovatelé

  • Ředitel studie: Florence LE TINIER, MD, Centre Oscar Lambret, Lille
  • Ředitel studie: David PASQUIER, MD, PhD, Centre Oscar Lambret, Lille

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. listopadu 2031

Dokončení studie (Odhadovaný)

1. listopadu 2031

Termíny zápisu do studia

První předloženo

29. června 2026

První předloženo, které splnilo kritéria kontroly kvality

28. července 2026

První zveřejněno (Aktuální)

29. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • LIN-LUNG-2504
  • 2026-A00128-43 (Jiný identifikátor: IDRCB)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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