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Table 1 Primary and secondary endpoints in the EGeSOR trial

From: Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR)

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