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Studies

Interventional Not yet recruiting

NCT07733219 on ClinicalTrials.gov

Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy on Ultra-central Lung Tumors on MR-Linac

Official title: Multicentre Phase II Trial Evaluating Stereotactic Body Radiotherapy (SBRT) on Ultra-central Lung Tumors on MR-Linac (Magnetic Resonance Image-Guided Radiotherapy)

  • Sponsor: Centre Oscar Lambret
  • Collaborators: Aquilab SAS, Centre François Baclesse (CTD-CNO)
  • Enrollment: 59 (Estimated)
  • Study start: 2026-09-01 (Estimated)
  • Primary completion: 2031-11-01 (Estimated)
  • Study completion: 2031-11-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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

Conditions

  • Ultracentral Pulmonary Tumors
  • Lung Cancer (T1 N0 M0 and T2 N0 M0)
  • Mediastinal Lymph Node Recurrence From All Types of Primary Cancer
  • Pulmonary Node Recurrence From All Types of Primary Cancer

Intervention / Treatment

  • Radiation: MRI-LINAC radiotherapy

Primary Outcome Measures

  • Incidence of late treatment-related toxicity (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.

Study Officials