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

28. Juli 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

59

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Florence LE TINIER, MD

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: MR-guided stereotactic radiotherapy (MR-LINAC)
Strahlung: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of late treatment-related toxicity
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Early and late adverse events (all grades)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centre Oscar Lambret

Mitarbeiter

Aquilab SAS
Centre François Baclesse (CTD-CNO)

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. November 2031

Studienabschluss (Geschätzt)

1. November 2031

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juli 2026

Zuerst gepostet (Tatsächlich)

29. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • LIN-LUNG-2504
  • 2026-A00128-43 (Andere Kennung: IDRCB)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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