Primary endpoint
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6 months after randomisation
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Composite criterion including
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- death,
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- at least 2-point decrease in the Activities of Daily Living (ADL) score versus baseline
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- at least 10% decrease in body weight versus baseline
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Secondary endpoints
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6, 12, and 24 months after randomisation
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- each component of the primary endpoint
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- progression-free survival
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- in-hospital death
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- unplanned admissions
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- post-surgery hospital stay length
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- discharge to home or nursing home
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- final cancer treatment plan (surgery, chemotherapy, targeted therapies, radiotherapy, and/or supportive care, alone or combined)
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- quality of life assessed by EORTC QLQ-C30 and specific module for head and neck cancer H&N35
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- treatment toxicities and/or complications: chemotherapy toxicities according to Classification Common Terminology Criteria for Adverse Events (CTCAE version 4.02)
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- cancer treatment feasibility
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- costs |