To determine whether in patients with EGFR mutated advanced NSCLC and osimertinib as first-line treatment, the (repeated) use of LAT to ≤ 3 OP lesions and continuation of first-line osimertinib, improves the median progression-free survival by more than 3 months (i.e. PFS2-PFS1 = \>3 months).
The (repeated) use of LAT to ≤ 3 OP lesions with continuation of first-line osimertinib, is endorsed by international guidelines (NCCN, ESMO). In this phase IIb prospective non-randomized observational trial, we want to document the benefit of LAT in this patient cohort.
Study Type
OBSERVATIONAL
Enrollment
39
Stereotactic body radiotherapy
Surgery
UZLeuven
Leuven, Belgium
RECRUITINGPFS 2
Progression Free Survival 2
Time frame: Time from start of osimertinib until first PD after LAT or death whichever comes first, up to 3 year after LAT
Time to next line systemic therapy
Time frame: Time from LAT until initiation of next line systemic therapy or death whichever comes first, up to 3 years after LAT
Patterns of disease progression
Patterns of disease progression after local ablative therapy (LAT) identified on sequential CT scans taken at 3 monthly intervals to document the natual history of the disease after LAT
Time frame: Time from LAT until disease progression or death whichever comes first, up to 3 years after LAT
Radiotherapy induced toxicity
Acute and late radiotherapy induced toxicities assessed using the CTCAE v4.0. and the RTOG/EORTC late morbidity score. Acute events are defined as ≤ 90 days post SBRT and late events \> 90 days.
Time frame: Change in toxicity measured from baseline up to 3 years after radiotherapy
Quality of life
Quality of life is measured by the EORTC QLQ-LC13 questionnaire comprised both of multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia).
Time frame: Change in quality of life measured from baseline up to 3 years after radiotherapy
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