Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy on Ultra-central Lung Tumors on MR-Linac (LIN-LUNG-2504)
Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy (SBRT) on Ultra-central Lung Tumors on MR-Linac (Magnetic Resonance Image-Guided Radiotherapy)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Florence LE TINIER, MD
研究連絡先のバックアップ
- 名前：Alicia PROBST, PhD
- 電話番号：+33 (0)3 20 29 59 18
- メール：promotion@o-lambret.fr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of late treatment-related toxicity
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Early and late adverse events (all grades)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Florence LE TINIER, MD、Centre Oscar Lambret, Lille
- スタディディレクター：David PASQUIER, MD, PhD、Centre Oscar Lambret, Lille
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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