About this trial
This is a phase II, non-randomised study examining the safety of treating high risk centrally located non-small cell lung cancer (NSCLC) tumours and single pulmonary oligometastatic lesions using radiation therapy (RT), for patients whose disease is inoperable. The method of delivering the RT in this study is image guided stereotactic ablative radiation therapy (IG-SABR). This method involves using imaging to ensure the radiation is being delivered to the correct location within the body and using higher than normal doses per treatment (fraction) to treat the lung cancer (NSCLC)/oligometastatic lung lesion. This study aims to determine its safety by looking at the number and severity of side effects. This study will deliver 8 treatments/fractions of RT with 7.5 Gy delivered in each fraction. To be eligible for this study the initial treatment plan for the patient must be shown to not fulfil certain criteria relating to doses to the tumour and surrounding normal tissue. This study has its own study specific criteria which must be adhered to. Translational sub-studies (optional) are open to patients in participating centres only. Patients will have the option to consent to participating in both translational studies or to neither.
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 0-2
Disqualifiers
Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin)) which is likely to interfere with treatment or assessment of outcomes
Tumour/oligometastatic lesion that is abutting the oesophagus
Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC
Spinal canal involvement
Trial design
Treatments tested in this trial
- Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)
Treatment groups
Sponsors and collaborators
Cancer Trials Ireland
Lead sponsor
Technological University Dublin
Collaborator
University College Dublin
Collaborator