Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy (SBRT) on Ultra-central Lung Tumors on MR-Linac (Magnetic Resonance Image-Guided Radiotherapy)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 59
- 主要终点
- Incidence of late treatment-related toxicity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Incidence of late treatment-related toxicity
时间窗: 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.
次要结局
- Early and late adverse events (all grades)(From radiotherapy simulation up to 36 months post-radiotherapy)
- Feasibility of MR-guided radiotherapy(from treatment initiation up to 3 months after completion of radiotherapy)
- Progression-Free Survival (PFS)(from treatment initiation to progression or death, assessed up to 36 months)
- Overall Survival (OS)(from treatment initiation up to 36 months)
- Local, regional, and distant disease control(at 6, 12, 24, and 36 months after treatment)
- FEV1 lung test(at baseline, and at 6, 18, and 30 months post-treatment)
- Dosimetric parameters related to target coverage (GTV, CTV, PTV)(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(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)(at baseline, and at 6, 18, and 30 months post-treatment)