Study Protocol of the NVALT25-ELDAPT Trial: Selecting the Optimal Treatment for Older Patients With Stage III Non-small-cell Lung Cancer

Background: Patients aged 75 years or older with stage III non-small-cell lung cancer (NSCLC) are underrepresented in clinical trials, leading to a lack of evidence for selection of the optimal treatment strategy. Information on benefits and harms of concurrent chemoradiotherapy among medically fit elderly patients is largely unknown, and reliable tools are needed to distinguish fit from frail patients for treatment selection. Also, information regarding quality of life during and after treatment is scarce. Patients and Methods: This multicenter NVALT25-ELDAPT (Dutch Association of Chest Physicians Trial Number 25 - Elderly with locally advanced Lung cancer: Deciding through geriatric Assessment on the oPtimal Treatment strategy) trial (NCT02284308) consists of a phase III randomized trial in combination with an observational study for all patients who do not participate in the randomized trial. The first aim of this study is to develop a reliable and clinically applicable screening tool to distinguish medically fit from frail patients. All patients >= 75 years diagnosed with stage III NSCLC are invited to undergo extensive geriatric assessment (part I). The second aim is to compare treatment tolerance, survival, and quality of life between concurrent and sequential chemoradiotherapy in fit patients (randomized trial, part II). For all patients, overall survival adjusted for quality of life (quality-adjusted survival) is described for each category of fitness and treatment strategy during and after treatment. Conclusion: With the results of the NVALT25-ELDAPT trial, treatment selection can be optimized and the best possible outcomes for each individual older patient with stage III NSCLC can be achieved. (C) 2018 Elsevier Inc. All rights reserved.