OPTIMISE Lung SABR
ConditionNon Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Trials Ireland
About this trial
This study is a phase II multi-centre, randomised study independently evaluating five fraction Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) and three fraction IG-SABR for patients with a peripherally located T1-T2 and selected T3 and T4 lung tumours, or a peripherally located single pulmonary oligometastatic lesion.
Eligibility criteria
Qualifiers
Written informed consent obtained prior to any study-specific procedures.
≥ 18 years of age.
Life expectancy >6 months.
ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
Disqualifiers
Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma which is likely to interfere with treatment or assessment of outcomes.
Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC.
Malignant spinal canal involvement.
Patients with syndromes or conditions associated with increased radiosensitivity.
Trial design
Treatments tested in this trial
- Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment
- Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)
Treatment groups
208 Participants
are divided into 2 treatment groupsSponsors and collaborators
Cancer Trials Ireland
Lead sponsor
Focas Research Institute, Technological University Dublin
Collaborator
Source ClinicalTrials.gov