Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease - An Open Label Randomized Phase III Trial Comparing Up-front Radiation in Oligometastatic Non-small Cell Lung Cancer (NSCLC) and Systemic Treatment With Systemic Treatment Alone
This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. The systemic treatment consists of chemotherapy/chemoimmunotherapy or immunotherapy and is given according to local practice. During the first 3 months of systemic treatment, aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions. Preferably with SBRT /SRT/SRS but conventional radiotherapy may also be used. After the first three cycles of systemic treatment, the patients are assessed, and after four cycles, they are continuing maintenance therapy if indicated. The patients are followed with radiology every three months.
• Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening procedures
‣ Histological or cytological diagnosis of NSCLC
⁃ Stage IV disease with ≤5 metastases (not including primary tumour or mediastinal nodes, N1-N3)
⁃ Patient deemed fit for first line chemoimmunotherapy, immunotherapy or chemotherapy
⁃ Extra-thoracic metastases accessible for stereotactic body radiotherapy (SBRT)
⁃ Thoracic tumour(s) accessible for SBRT or conventional radiotherapy
⁃ Received no prior systemic treatment or radiation therapy for NSCLC (previous adjuvant systemic therapy is allowed)
⁃ Age \> 18 years at time of study entry, no upper age limit
⁃ WHO performance status 0-2
⁃ Adequate normal organ and marrow function Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects.
∙ Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up