研究目的
To improve early detection of treatable relapse of lung cancer, thereby improving patient survival and quality of life (QoL).
研究成果
This trial combining collection of data regarding imaging, QoL, liquid biopsy, and cost in a multicenter randomized clinical setting will provide the scientific basis for improving surveillance and treatment of patients with lung cancer as well as provide knowledge transferable to other groups of cancer patients.
研究不足
The study does not address the potential for PET/ceCT to detect relapses earlier than ceCT in all patient subgroups, nor does it fully explore the implications of detecting relapses earlier on overall survival and quality of life.
The study is an investigator-initiated national multicenter randomized clinical trial designed first to assess if surveillance with 18F-?udeoxyglucose positron emission tomography (PET)/ceCT can increase the number of treatable relapses, and second to concurrently collect liquid biopsy samples for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse. The aim is to include and randomize a total of 750 patients from all 5 regions of Denmark from the departments of pulmonology and oncology with stage I-III nonesmall-cell lung cancer (NSCLC) after treatment with curative intent. These patients are currently, after their definitive treatment, followed with ceCT (thorax and upper abdomen) every 3 months for the first 2 years. In the trial, patients will be randomized 1:1 to the interventional arm (arm A) with PET/ceCT (vertex to the midfemoral region) replacing ceCT at months 6, 12, 18, and 24, or to the standard arm (arm B) with ceCT every 3 months. In both arms, patients will undergo clinical evaluation, QoL assessment, and liquid biopsy sampling every 3 months. Patients will be stratified by site, sex, and lung cancer stage.
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