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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Combined systemic therapy + radiation
Chemoimmunotherapy or immunotherapy
Dept of Oncology
Gothenburg, Sweden
Dept of pulmonary medicine
Linköping, Sweden
Dept of pulmonary medicine
Lund, Sweden
Dept of Oncology
Stockholm, Sweden
Dept. of Oncology
Umeå, Sweden
Dept. of Oncology
Uppsala, Sweden
Overall survival (OS)
Time to death
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Progression-free survival (PFS)
Time to progressive disease or death
Time frame: From date of randomization until the date of first documented systemic progression or date of death from any cause, whichever came first, assessed up to 60 months
Local control (LC)
Percentage complete, partial remission or stable disease
Time frame: At 12 months after randomization
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