Quality of Life Clinical Trial
Official title:
Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.
Primary objective: To assess whether the addition of radiotherapy to the remaining thoracic
tumor burden following standard medical treatment results in a superior quality of life
measured with lung cancer symptom scale (LCSS) in patients with stage IV non-small cell lung
cancer. The comparison will be made at three months after randomization.
Secondary objectives: Overall survival, progression-free survival, toxicity and longitudinal
quality of life measurements.
Design: Multicentre, randomized, phase III trial. Patients will be registered for the study
up-front but randomization will be performed after evaluation of response, three months after
initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy.
Randomization will be to thoracic radiotherapy or follow-up (1:1).
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